Import Alert 54-16

(Note: This import alert represents the Agency's current guidance to FDA field personnel regarding the manufacturer(s) and/or products(s) at issue. It does not create or confer any rights for or on any person, and does not operate to bind FDA or the public).

Import Alert # 54-16
Published Date: 02/13/2019
Type: DWPE

Import Alert Name:

"DETENTION WITHOUT PHYSICAL EXAMINATION OF PRODUCTS THAT ARE MARKETED AS FOODS, INCLUDING PRODUCTS MARKETED AS DIETARY SUPPLEMENTS, THAT CONTAIN AN ACTIVE PHARMACEUTICAL INGREDIENT"

Reason for Alert:

FDA field investigations and laboratory analyses have concluded that a number of imported products marketed as dietary supplements that are often promoted for sexual enhancement, weight loss, muscle building, lifestyle, and other claims, contain undeclared active pharmaceutical ingredients (APIs).

FDA investigations find the APIs include:
• anticoagulants (e.g., Warfarin)
• anticonvulsants (e.g., Phenytoin)
• HMG-CoA reductase inhibitors (e.g., Lovastatin),
• Phosphodiesterase type 5 inhibitors (e.g., Sildenafil)
• prescription nonsteroidal anti-inflammatory drugs (NSAIDS) (e.g., Indomethacin)
• beta-blockers (e.g., Propranolol)
• controlled substances (Benzodiazepines and anabolic
steroids)
• APIs removed from the market for reasons of safety or efficacy (e.g., Sibutramine)
• novel synthetic steroids, and new chemicals ingredients of unknown safety and efficacy.

These APIs, because of their toxicity or other potential for harmful effect, or the method of their use, or the collateral measures necessary for their use, are not safe for use except under the supervision of a practitioner licensed by law to administer such products.

FDA analyses and investigations revealed that these products frequently contain the same APIs, or analogues of APIs, that are in FDA-approved drugs. Depending on the circumstances, these products are misbranded and unapproved new drugs, or adulterated food under the Federal Food, Drug, and Cosmetic Act.

Guidance:

Districts may detain without physical examination the specified products from the firms listed in the Red List of this import alert.

Districts should submit a recommendation for addition to the Red List when detained products appear to meet the criteria in this alert, and are not listed on the Red list of this import alert. DIO and FDA's Center for Drug Evaluation and Research (CDER) or FDA's Center for Food Safety and Applied Nutrition (CFSAN) will evaluate regulatory recommendations on a case-by-case basis.

For any product purporting to be or otherwise marketed as a food, including a product marketed as a dietary supplement that is not covered by an approved new drug application (NDA), an approved abbreviated new drug application (ANDA), or other limited exemptions under the Federal Food, Drug, and Cosmetic Act (and applicable regulations) from the requirement for an approved application, and contains an API, or an analogue of an API described above, misbranded drug and unapproved new drug, or adulterated food charges may be appropriate based on the criteria described below.

Unapproved new drug and misbranded drug

For any product purporting to be or otherwise marketed as a food, including a product marketed as a dietary supplement, whose labeling indicates that the product appears to be intended for use as a drug, under Section 201(g)(1)(B), the unapproved new drug [Section 505(a)] and misbranded drug [Section 502(f)(1) & (f)(2)] charges are appropriate.

For a product purporting to be or otherwise marketed as a food, including a product marketed as a dietary supplement, that is excluded from the definition of a dietary supplement under Section 201(ff)(3)(B) and whose labeling indicates that the product appears to be intended for use as a drug, under Section 201(g)(1)(C), the unapproved new drug [Section 505(a)] and misbranded drug [Section 502(f)(1) & (f)(2)] charges are appropriate.

Adulterated food

For a product purporting to be or otherwise marketed as a food, including a product marketed as a dietary supplement, but whose labeling does not indicate that the product appears to be intended for use as a drug, the adulterated food [Section 402(a)(2)(c)] charge is appropriate because the APIs of the type identified above are unsafe food additives within the meaning of section 409 of the Act. A food product to which such an API is added is considered to be adulterated as defined in section 402(a)(2)(c) of the Act. The APIs of the type identified above also represent a poisonous or deleterious substance in food; therefore the adulterated food [Section 402(a)(1)] charge is also appropriate.

INFORMATION FOR FIRMS REQUESTING REMOVAL FROM THE RED LIST:

In order to be removed from the red list, the firm should submit evidence to FDA establishing that the conditions that gave rise to the appearance of the violation have been resolved, so that the agency will have confidence that future entries will be in compliance with the Act.

For additional guidance on removal from detention without physical examination, refer to FDA's Regulatory Procedures Manual, Chapter 9, Section 9-6, "Detention Without Physical Examination (DWPE)."

All requests for removal from detention without physical examination may be sent via email to: importalerts2@fda.hhs.gov

Or mailed to:

Food and Drug Administration
Division of Import Operations
12420 Parklawn Drive, ELEM-3109
Rockville, MD 20857

Requests for removal from detention without physical examination will be reviewed by DIO and referred to CDER Imports Exports Compliance Branch or CFSAN Office of Compliance, Division of Enforcement, Labeling and Dietary Supplement Compliance Branch for additional evaluation. The Center will review analytical data, labels, and labeling submitted in support of removal of products from detention without physical examination.

For questions or issues involving import operations, contact DIO's Import Operations and Maintenance Branch at (301) 796-0356.

For questions or issues concerning science, science policy, sample
collection, analysis, preparation, or analytical methodology,
contact the Office of Regulatory Science at (301) 796-6600.

Product Description:

PRODUCTS: Dietary Supplements
Unapproved New Drugs
Misbranded Drugs

PRODUCT
CODE: "See Red List"

PROBLEM: Unapproved New Drugs; Misbranded Drugs,
Unapproved Food Additive; Adulterated Food

Charge:

"The article is subject to refusal of admission pursuant to
Section 801(a)(3) in that it appears to be a new drug within the meaning of Section 201(p) without an effective new drug application (NDA)[Unapproved New Drug, Section 505(a)]"
OASIS Charge Code: UNAPPROVED

"The article is subject to refusal of admission pursuant to
Section 801(a)(3) in that it appears to be a drug within the meaning of Section 201(g) that lacks adequate directions for use. [Misbranded, Section 502(f)(1)]"
OASIS Charge Code: DIRECTIONS

“The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to bear or contain a poisonous or deleterious substance which may render the article injurious to health. [Adulteration, Section 402(a)(1)]” Contains:
OASIS Charge Code: POISONOUS

"The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be adulterated because it appears to bear or contain a food additive that is unsafe within the meaning of Section 409 [Adulteration, Section 402(a)(2)(C)]"
OASIS Charge Code: UNSAFE ADD

List of firms and their products subject to Detention without Physical Examination (DWPE) under this Import Alert (a.k.a. Red List)


BRAZIL


Michelle Gleneuine
Date Published : 05/11/2015
Av. Canal Marapendi No , 4100/ 1105 BL1 , Rio de Janeiro, RJ BRAZIL
54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 05/11/2015

Desc: PEB One and PEB Two Capsules (Brand Renutryent) Dietary Supplement
Notes: Product contains undeclared Fenproporex HCL and Chlordiazepoxide HCL.

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 05/11/2015

Desc: PEB One and PEB Two Capsules (Brand Renutryent) Dietary Supplement
Notes: Product contains undeclared Fenproporex HCL and Chlordiazepoxide HCL.


CANADA


Nugale Pharmaceutical Inc.
Date Published : 04/14/2015
41 Pullman Crt , Scarborough, Ontario CANADA
54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 04/14/2015

Desc: Slimquick Green Coffee Bean Softgel
Notes: FDA analysis found Sibutramine; N-desmethyl Sibutramine; and Phenolphthalein in product.

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 04/14/2015

Desc: Slimquick Green Coffee Bean Softgel
Notes: FDA analysis found Sibutramine; N-desmethyl Sibutramine; and Phenolphthalein in product.


CHINA


BEIJING JIANYANG HEALTH PRODUCT CO., LTD
Date Published : 05/07/2015
Liren Street , Beiging , Beijing, Beijing CHINA
54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 05/07/2015

Desc: Super Shanghai Strong Testis Capsules "Dietary Supplement"
Notes: Product contains undeclared Sibutramine.

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 05/07/2015

Desc: Super Shanghai Strong Testis Capsules "Dietary Supplement"
Notes: Product contains undeclared Sibutramine.

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 05/07/2015

Desc: Super Shanghai Strong Testis Capsules "Dietary Supplement"
Notes: Product contains undeclared Sibutramine.

Beijing Kowloon Pharmaceutical Factory
Date Published : 06/29/2015
No 1200 Diyang Bldg , Beijing, CHINA
54 C - - 02 L-Arginine (Protein)
Date Published: 06/29/2015

Desc: 4Everon Sexual Stimulant Tablets (declared as L-Arginine dietary supplement)
Notes: Product contains undeclared chemical “Hydroxycetildenafil” an analog of Sildenafil.

54 F - - 29 Yohimbe (Herbal & Botanicals, not Teas)
Date Published: 06/29/2015

Desc: 4Everon Sexual Stimulant Tablets (declared as L-Arginine dietary supplement)
Notes: Product contains undeclared chemical “Hydroxycetildenafil” an analog of Sildenafil.

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 06/29/2015

Desc: 4Everon Sexual Stimulant Tablets (declared as L-Arginine dietary supplement)
Notes: Product contains undeclared chemical “Hydroxycetildenafil” an analog of Sildenafil.

65 P - - 02 Sildenafil Citrate (Regulator)
Date Published: 06/29/2015

Desc: 4Everon Sexual Stimulant Tablets (declared as L-Arginine dietary supplement)
Notes: Product contains undeclared chemical “Hydroxycetildenafil” an analog of Sildenafil.

Casco Blu Qingdao
Date Published : 09/28/2016
N3 P Rm , 901 Yishi Yijia Buildin No.6 , Qingdao, CHINA
31 K - - 02 Tea, Green
Date Published: 09/28/2016

Desc: Green Tea/ White Willow Bark Extract
Notes: Sildenafil
Problems: OXYTETRACYCLINE;

54 F - - 28 Willowbark (Herbal & Botanicals, not Teas)
Date Published: 09/28/2016

Desc: Green Tea/ White Willow Bark Extract
Notes: Sildenafil
Problems: OXYTETRACYCLINE;

54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 09/28/2016

Desc: Green Tea/ White Willow Bark Extract
Notes: Sildenafil
Problems: OXYTETRACYCLINE;

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 09/28/2016

Desc: Green Tea/ White Willow Bark Extract
Notes: Sildenafil
Problems: OXYTETRACYCLINE;

ELT Technology
Date Published : 04/17/2015
10f Tech-Building East Heping Road , Longhua Street, Baoan District Shenzhen , Guangdong, CHINA
31 - - - -- Coffee/Tea
Date Published: 04/17/2015

Desc: Lose Weight Coffee Slim Delicious
Notes: FDA analysis found Sibutramine and Desmethyl Sibutramine in product.

60 R - - 19 Sibutramine HCL Monohydrate (Anorexic)
Date Published: 04/17/2015

Desc: Lose Weight Coffee Slim Delicious
Notes: FDA analysis found Sibutramine and Desmethyl Sibutramine in product.

Eagene Biotechnology Co., Ltd.
Date Published : 05/12/2015
Room 1301,Block A,China World Trade , Center,No. 41,Minzu Avenue , Nanning, CN-45 CHINA
54 G - - 99 Animal By-Products and Extracts, N.E.C.
Date Published: 05/12/2015

Desc: Rocket Fuel (Oyster Peptide Tablets)
Notes: Product contains undeclared N-Desmethyl-Tadalafil (Nortadalafil)

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 05/12/2015

Desc: Rocket Fuel (Oyster Peptide Tablets)
Notes: Product contains undeclared N-Desmethyl-Tadalafil (Nortadalafil)

66 S - - 51 Tadalafil
Date Published: 05/12/2015

Desc: Rocket Fuel (Oyster Peptide Tablets)
Notes: Product contains undeclared N-Desmethyl-Tadalafil (Nortadalafil)

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 05/12/2015

Desc: Rocket Fuel (Oyster Peptide Tablets)
Notes: Product contains undeclared N-Desmethyl-Tadalafil (Nortadalafil)

66 Y - - 99 Exhibits - Other Drug Related Items N.E.C.
Date Published: 05/12/2015

Desc: Rocket Fuel (Oyster Peptide Tablets)
Notes: Product contains undeclared N-Desmethyl-Tadalafil (Nortadalafil)

Guangzhou Garden City (Biological) Health Food Factory
Date Published : 04/23/2015
No. 128 Guangzhou Avenue , Dasan Industrial Park North , Guangzhou, CHINA
54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 04/23/2015

Desc: La Jiao Shou Shen
Notes: Product contains undeclared sibutramine and phenolphthalein.

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 04/23/2015

Desc: La Jiao Shou Shen
Notes: Product contains undeclared sibutramine and phenolphthalein.

Guangzhou Meilai Biotechnology Co., Ltd.
Date Published : 04/23/2015
No.128 North Guangzhou Ave , Chashan Industrial Park , Guangzhou, CHINA
54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 04/23/2015

Desc: La Jiao Shou Shen
Notes: Product contains undeclared sibutramine and phenolphthalein

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 04/23/2015

Desc: La Jiao Shou Shen
Notes: Product contains undeclared sibutramine and phenolphthalein

Guangzhou Yan Xiang Co, LTD
Date Published : 05/19/2015
105 Shahe Rd. , Baiyun Guangzhou, Guangdong CHINA
54 Y - - 06 Bee Pollen (Vit/Min/Protein/Unconventional Dietary Spec for Human/Animal, N.E.C.)
Date Published: 05/19/2015

Desc: Ultimate Formula Bee Pollen Capsules
Notes: FDA analysis found undeclared Sibutramine in product.

60 R - - 19 Sibutramine HCL Monohydrate (Anorexic)
Date Published: 05/19/2015

Desc: Ultimate Formula Bee Pollen Capsules
Notes: FDA analysis found undeclared Sibutramine in product

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 05/19/2015

Desc: Ultimate Formula Bee Pollen Capsules
Notes: FDA analysis found undeclared Sibutramine in product

HENGS JEWELLRY LTD
Date Published : 02/15/2018
Huan Shi Room 111 , East Rd , Guangzhou, Guangdong CHINA
31 A - - -- Coffee
Date Published: 02/15/2018

Desc: H.I. Coffee (Herbal Instant Coffee)
Notes: FDA laboratory analysis confirmed product contains undeclared Desmethyl Carbodenafil; an analogue of Sildenafil.

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 02/15/2018

Desc: H.I. Coffee (Herbal Instant Coffee)
Notes: FDA laboratory analysis confirmed product contains undeclared Desmethyl Carbodenafil; an analogue of Sildenafil.

65 P - - 02 Sildenafil Citrate (Regulator)
Date Published: 02/15/2018

Desc: H.I. Coffee (Herbal Instant Coffee)
Notes: FDA laboratory analysis confirmed product contains undeclared Desmethyl Carbodenafil; an analogue of Sildenafil.

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 02/15/2018

Desc: H.I. Coffee (Herbal Instant Coffee)
Notes: FDA laboratory analysis confirmed product contains undeclared Desmethyl Carbodenafil; an analogue of Sildenafil.

Kunming DaLi Industry & Trade Co., Ltd
Date Published : 04/01/2015
372 West Renmin Road , Kunming, Yunnan, Cn-53 CHINA
54 - - - -- Vit/Min/Prot/Unconv Diet(Human/Animal)
Date Published: 04/01/2015

Notes: All Dietary Supplements;Problem(s): APIs found in dietary supplement products

55 - - - -- Pharm Necess & Ctnr For Drug/Bio
Date Published: 04/01/2015

Notes: All Drug Products; Problem(s): APIs found in dietary supplement products

60 - - - -- Human and Animal Drugs
Date Published: 04/01/2015

Notes: All Drug Products; Problem(s): APIs found in dietary supplement products

61 - - - -- Human and Animal Drugs
Date Published: 04/01/2015

Notes: All Drug Products; Problem(s): APIs found in dietary supplement products

62 - - - -- Human and Animal Drugs
Date Published: 04/01/2015

Notes: All Drug Products; Problem(s): APIs found in dietary supplement products

63 - - - -- Human and Animal Drugs
Date Published: 04/01/2015

Notes: All Drug Products; Problem(s): APIs found in dietary supplement products

64 - - - -- Human and Animal Drugs
Date Published: 04/01/2015

Notes: All Drug Products; Problem(s): APIs found in dietary supplement products

65 - - - -- Human and Animal Drugs
Date Published: 04/01/2015

Notes: All Drug Products; Problem(s): APIs found in dietary supplement products

66 - - - -- Human and Animal Drugs
Date Published: 04/01/2015

Notes: All Drug Products; Problem(s): APIs found in dietary supplement products

La Sha City Limited Company
Date Published : 05/15/2015
La Sha City Liberation Road no. 168 , La Sha City, Tibet CHINA
54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 05/15/2015

Desc: France T253 Tablets
Notes: Problem(s);Sildenafil found in product

65 P - - 02 Sildenafil Citrate (Regulator)
Date Published: 05/15/2015

Desc: France T253 Tablets
Notes: Problem(s);Sildenafil found in product

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 05/15/2015

Desc: France T253 Tablets
Notes: Problem(s);Sildenafil found in product

66 Y - - 99 Exhibits - Other Drug Related Items N.E.C.
Date Published: 05/15/2015

Desc: France T253 Tablets
Notes: Problem(s);Sildenafil found in product

Much New Limited
Date Published : 07/07/2015
8 STORY HUANGYAN MANSION , Huangyan, Zhejiangsheng CHINA
54 F - - 50 Hawthorn (Herbal & Botanicals, not Teas)
Date Published: 07/07/2015

Desc: Slim 30 (Natural Herb Supplement for weight loss)
Notes: Slim 30 was found to contain undeclared Desmethyl Sibutramine

54 F - - 50 Hawthorn (Herbal & Botanicals, not Teas)
Date Published: 07/07/2015

Desc: Joyful Slim (Puerarin- Chinese Yim Powder)
Notes: Slim 30 was found to contain undeclared Desmethyl Sibutramine

54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 07/07/2015

Desc: Slim 30 (Natural Herb Supplement for weight loss)
Notes: Slim 30 was found to contain undeclared Desmethyl Sibutramine

54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 07/07/2015

Desc: Joyful Slim (Puerarin- Chinese Yim Powder)
Notes: Slim 30 was found to contain undeclared Desmethyl Sibutramine

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 07/07/2015

Desc: Joyful Slim (Puerarin- Chinese Yim Powder)
Notes: Slim 30 was found to contain undeclared Desmethyl Sibutramine

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 07/07/2015

Desc: Slim 30 (Natural Herb Supplement for weight loss)
Notes: Slim 30 was found to contain undeclared Desmethyl Sibutramine

NET D ACTIVE NUTRA TRADING CO.
Date Published : 06/22/2015
15 YONGJIANG ROAD , BEILUN NETD , NINGBO, Cn-Nota CHINA
54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 06/22/2015

Desc: Blue Steel Dietary Supplement
Notes: Product contains undeclared Thianone; an analog of Sildenafil

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 06/22/2015

Desc: Blue Steel Dietary Supplement
Notes: Product contains undeclared Thianone; an analog of Sildenafil

No. 8 IIAlley
Date Published : 05/04/2015
xia shi wei district , hu yong town baon district , guangdong, CHINA
54 - - - -- Vit/Min/Prot/Unconv Diet(Human/Animal)
Date Published: 05/04/2015

Notes: All Dietary Supplements;APIs found in dietary supplement products

55 - - - -- Pharm Necess & Ctnr For Drug/Bio
Date Published: 05/04/2015

Notes: All Drug Products;APIs found in dietary supplement products

60 - - - -- Human and Animal Drugs
Date Published: 05/04/2015

Notes: All Drug Products;APIs found in dietary supplement products

61 - - - -- Human and Animal Drugs
Date Published: 05/04/2015

Notes: All Drug Products;APIs found in dietary supplement products

62 - - - -- Human and Animal Drugs
Date Published: 05/04/2015

Notes: All Drug Products;APIs found in dietary supplement products

63 - - - -- Human and Animal Drugs
Date Published: 05/04/2015

Notes: All Drug Products;APIs found in dietary supplement products

64 - - - -- Human and Animal Drugs
Date Published: 05/04/2015

Notes: All Drug Products;APIs found in dietary supplement products

65 - - - -- Human and Animal Drugs
Date Published: 05/04/2015

Notes: All Drug Products;APIs found in dietary supplement products

66 - - - -- Human and Animal Drugs
Date Published: 05/04/2015

Notes: All Drug Products;APIs found in dietary supplement products

Qinghai Baojiantang Pharmaceutical Co., Ltd
Date Published : 09/25/2015
Peopleżżżs Road 168 , Qinghai, CHINA
54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 09/25/2015

Desc: Male Sexual Stimulant- U.S.A. Wolf Brother Strong Man
Notes: Product was found to contain undeclared Sildenafil

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 09/25/2015

Desc: Male Sexual Stimulant- U.S.A. Wolf Brother Strong Man
Notes: Product was found to contain undeclared Sildenafil

66 Y - - 99 Exhibits - Other Drug Related Items N.E.C.
Date Published: 09/25/2015

Desc: Male Sexual Stimulant- U.S.A. Wolf Brother Strong Man
Notes: Product was found to contain undeclared Sildenafil

Rizhao Rande Trading
Date Published : 08/01/2016
No. 108 Heping Rd. , Shanghai, CHINA
54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 08/01/2016

Desc: Fuel Up High Octane Pills
Notes: Product contains hydroxythiohomosildenafil (structurally similar to sildenafil) per FDA analysis. Product may be invoiced and shipped as bulk red pills. ;

54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 08/01/2016

Desc: Fuel Up Plus Pills
Notes: Product contains hydroxythiohomosildenafil (structurally similar to sildenafil) per FDA analysis. Product may be invoiced and shipped as bulk red pills.

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 08/01/2016

Desc: Fuel Up Plus Pills
Notes: Product contains hydroxythiohomosildenafil (structurally similar to sildenafil) per FDA analysis. Product may be invoiced and shipped as bulk red pills. ;

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 08/01/2016

Desc: Fuel Up High Octane Pills
Notes: Product contains hydroxythiohomosildenafil (structurally similar to sildenafil) per FDA analysis. Product may be invoiced and shipped as bulk red pills. ;

65 P - - 02 Sildenafil Citrate (Regulator)
Date Published: 08/01/2016

Desc: Fuel Up High Octane Pills
Notes: Product contains hydroxythiohomosildenafil (structurally similar to sildenafil) per FDA analysis. Product may be invoiced and shipped as bulk red pills

65 P - - 02 Sildenafil Citrate (Regulator)
Date Published: 08/01/2016

Desc: Fuel Up Plus Pills
Notes: Product contains hydroxythiohomosildenafil (structurally similar to sildenafil) per FDA analysis. Product may be invoiced and shipped as bulk red pills. ;

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 08/01/2016

Desc: Fuel Up Plus Pills
Notes: Product contains hydroxythiohomosildenafil (structurally similar to sildenafil) per FDA analysis. Product may be invoiced and shipped as bulk red pills. ;

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 08/01/2016

Desc: Fuel Up High Octane Pills
Notes: Product contains hydroxythiohomosildenafil (structurally similar to sildenafil) per FDA analysis. Product may be invoiced and shipped as bulk red pills

Sha Double Nutra Biotech Coltd
Date Published : 05/23/2016
11C No 1 Bldg 2005 Huangxing Rd , Shanghaishanghai, CHINA
54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 05/23/2016

Desc: Adrafinil capsules

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 05/23/2016

Desc: Anricetam Capsules

Shenzhen Baoyitong
Date Published : 10/26/2016
Yi Wu 20E of the Habitat , Wenjin Road North , Shenzhen , Luohu District CHINA
54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 10/26/2016

Desc: Aulijing Zi Su Body Fat Health II Dietary Supplement
Notes: FDA laboratory analysis confirmed product contains undeclared Sibutramine and Phenolphthalein.

66 F - - 99 Suppressant N.E.C.
Date Published: 10/26/2016

Desc: Aulijing Zi Su Body Fat Health II Dietary Supplement
Notes: FDA laboratory analysis confirmed product contains undeclared Sibutramine and Phenolphthalein.

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 10/26/2016

Desc: Aulijing Zi Su Body Fat Health II Dietary Supplement
Notes: FDA laboratory analysis confirmed product contains undeclared Sibutramine and Phenolphthalein.

Suzhou MyLand Pharm&Nutrition Inc.
Date Published : 11/09/2015
Hejing Fenghui Internation Suite 20 202 , Wenling Rd; Xiangcheng , Suzhou, Jiangsu CHINA
54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 11/09/2015

Desc: Propolis Extract Powder
Notes: FDA analysis detected Tianeptine in product

61 N - - 99 Anti-Depressant N.E.C.
Date Published: 11/09/2015

Desc: Propolis Extract Powder
Notes: FDA analysis detected Tianeptine in product

TopLife International
Date Published : 10/04/2016
#1721, Mingchengguoji Center, No.98 , Mid-Furong Rd. Furong District , Changsha, Hunan CHINA
54 E - - 99 Herbals & Botanical Teas, N.E.C.
Date Published: 10/04/2016

Desc: Meizi Evolution Slimming Softgel
Notes: FDA laboratory analysis confirmed product contains undeclared sibutramine

54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 10/04/2016

Desc: Meizi Evolution Slimming Softgel
Notes: FDA laboratory analysis confirmed product contains undeclared sibutramine

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 10/04/2016

Desc: Meizi Evolution Slimming Softgel
Notes: FDA laboratory analysis confirmed product contains undeclared sibutramine

60 R - - 19 Sibutramine HCL Monohydrate (Anorexic)
Date Published: 10/04/2016

Desc: Meizi Evolution Slimming Softgel
Notes: FDA laboratory analysis confirmed product contains undeclared sibutramine

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 10/04/2016

Desc: Meizi Evolution Slimming Softgel
Notes: FDA laboratory analysis confirmed product contains undeclared sibutramine

TopLife International (HK)
Date Published : 09/12/2016
1621, No 88, Dingwang Building , Furong Road , Changsha, Hunan CHINA
54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 09/12/2016

Desc: Mei Zi Super Power Fruits Capsules
Notes: FDA laboratory analysis confirmed product contains undeclared subutramine.

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 09/12/2016

Desc: Mei Zi Super Power Fruits Capsules
Notes: FDA laboratory analysis confirmed product contains undeclared subutramine.

60 R - - 19 Sibutramine HCL Monohydrate (Anorexic)
Date Published: 09/12/2016

Desc: Mei Zi Super Power Fruits Capsules
Notes: FDA laboratory analysis confirmed product contains undeclared subutramine

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 09/12/2016

Desc: Mei Zi Super Power Fruits Capsules
Notes: FDA laboratory analysis confirmed product contains undeclared subutramine

TopLife International Co., Ltd.
Date Published : 09/12/2016
No 388 Furong Mid Rd, Furong Dist , Changsha, Hunan CHINA
54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 09/12/2016

Desc: Mei Zi Super Power Fruits Capsules
Notes: FDA laboratory analysis confirmed product contains undeclared subutramine.

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 09/12/2016

Desc: Mei Zi Super Power Fruits Capsules
Notes: FDA laboratory analysis confirmed product contains undeclared subutramine.

60 R - - 19 Sibutramine HCL Monohydrate (Anorexic)
Date Published: 09/12/2016

Desc: Mei Zi Super Power Fruits Capsules
Notes: FDA laboratory analysis confirmed product contains undeclared subutramine

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 09/12/2016

Desc: Mei Zi Super Power Fruits Capsules
Notes: FDA laboratory analysis confirmed product contains undeclared subutramine

Zheng Xu Bin
Date Published : 11/10/2016
Huangshi Rd. , Baiyun District , Guangzhou, Guangdong CHINA
54 E - - 99 Herbals & Botanical Teas, N.E.C.
Date Published: 11/10/2016

Desc: Botanical Slimming Gold Version
Notes: FDA lab analysis found undeclared Sibutramine in product. Product is available for purchase by U.S. consumers on the website; http;//www.botanicalnow.com/online-store/!/~/cart.

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 11/10/2016

Desc: Botanical Slimming Gold Version
Notes: FDA lab analysis found undeclared Sibutramine in product. Product is available for purchase by U.S. consumers on the website; http;//www.botanicalnow.com/online-store/!/~/cart.

60 R - - 19 Sibutramine HCL Monohydrate (Anorexic)
Date Published: 11/10/2016

Desc: Botanical Slimming Gold Version
Notes: FDA lab analysis found undeclared Sibutramine in product. Product is available for purchase by U.S. consumers on the website; http;//www.botanicalnow.com/online-store/!/~/cart.

xuancheng baicao plants industry and trade co.,ltd
Date Published : 11/28/2014
xuancheng economic developing zone , Anhui, Anweisheng CHINA
54 E - - -- Herbal and Botanical
Date Published: 11/28/2014

Desc: Super ArthGold
Notes: Undeclared APIs

54 E - - -- Herbal and Botanical
Date Published: 11/28/2014

Desc: Pro ArthMax
Notes: Undeclared APIs


COLOMBIA


Herbal Nutraceutica Sas
Date Published : 09/25/2015
Avenida 5 200 , ; ; ; ; ; OESTE , Cali, Valle Del Cauca COLOMBIA
54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 09/25/2015

Desc: Ultra ZX Capsules
Notes: FDA analysis detected Sibutramine HCl in product.

60 R - - 19 Sibutramine HCL Monohydrate (Anorexic)
Date Published: 09/25/2015

Desc: Ultra ZX Capsules
Notes: FDA analysis detected Sibutramine HCl in product.

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 09/25/2015

Desc: Ultra ZX Capsules
Notes: FDA analysis detected Sibutramine HCl in product.


HONG KONG


Hong Kong Tianlong Technology International Group Company
Date Published : 05/15/2015
20/F , Hua Chiao Commercial Centre , Mong Kok, Kowloon HONG KONG
54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 05/15/2015

Desc: France T253 Tablets
Notes: Problem(s);Sildenafil found in product.

65 P - - 02 Sildenafil Citrate (Regulator)
Date Published: 05/15/2015

Desc: France T253 Tablets
Notes: Problem(s); Sildenafil found in product

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 05/15/2015

Desc: France T253 Tablets
Notes: Problem(s); Sildenafil found in product

66 Y - - 99 Exhibits - Other Drug Related Items N.E.C.
Date Published: 05/15/2015

Desc: France T253 Tablets
Notes: Problem(s);Sildenafil found in product

Hongkong Jiuyuejiu Biology Technology CO., LTD
Date Published : 06/01/2015
1226, Tsim Sha Tsui , Unknown, HONG KONG
54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 06/01/2015

Desc: Bull Tablets
Notes: Problem(s); Sildenafil and Tadalafil found in product.

65 P - - 02 Sildenafil Citrate (Regulator)
Date Published: 06/01/2015

Desc: Bull Tablets
Notes: Problem(s); Sildenafil and Tadalafil found in product.

66 S - - 51 Tadalafil
Date Published: 06/01/2015

Desc: Bull Tablets
Notes: Problem(s); Sildenafil and Tadalafil found in product.

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 06/01/2015

Desc: Bull Tablets
Notes: Problem(s); Sildenafil and Tadalafil found in product.

Jin Lian
Date Published : 01/25/2017
No. 122 Hong Kong Street , Kowloon , Bya kowloon Bay Horngjaan, HONG KONG
54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 01/25/2017

Desc: Black 4K Capsules (Bl4ck 4K)Dietary Supplement
Notes: FDA laboratory analysis confirmed product contains undeclared Sildenafil

65 P - - 02 Sildenafil Citrate (Regulator)
Date Published: 01/25/2017

Desc: Black 4K Capsules (Bl4ck 4K)Dietary Supplement
Notes: FDA laboratory analysis confirmed product contains undeclared Sildenafil

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 01/25/2017

Desc: Black 4K Capsules (Bl4ck 4K)Dietary Supplement
Notes: FDA laboratory analysis confirmed product contains undeclared Sildenafil

TopLife International
Date Published : 03/02/2017
Unknown , Unknown, HONG KONG
54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 03/02/2017

Desc: Mei Zi Super Power Fruits Capsules
Notes: FDA laboratory analysis confirmed product contains undeclared subutramine

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 03/02/2017

Desc: Mei Zi Super Power Fruits Capsules
Notes: FDA laboratory analysis confirmed product contains undeclared subutramine

60 R - - 19 Sibutramine HCL Monohydrate (Anorexic)
Date Published: 03/02/2017

Desc: Mei Zi Super Power Fruits Capsules
Notes: FDA laboratory analysis confirmed product contains undeclared subutramine

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 03/02/2017

Desc: Mei Zi Super Power Fruits Capsules
Notes: FDA laboratory analysis confirmed product contains undeclared subutramine

Wuhan 3B Scientific Corporation
Date Published : 07/17/2017
No. 122 HongKong Steer , Kowloon Bay, , Kowloon Bay, Horngjaan, HONG KONG
54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 07/17/2017

Desc: Vegetal Vigra Capsules
Notes: Product was found to contain undeclared Sildenafil

65 P - - 02 Sildenafil Citrate (Regulator)
Date Published: 07/17/2017

Desc: Vegetal Vigra Capsules
Notes: Product was found to contain undeclared Sildenafil


JAPAN


CBC CO., LTD.
Date Published : 10/17/2016
2-15-13 TSUKISHIMA CHUO-KU , TSUKISHIMA CHUO-KU, JAPAN
33 E - - -- Hard Candy W/O Nut/Fruit
Date Published: 10/17/2016

Desc: Ryukakusan Herbal Drops (All Flavors)
Notes: FDA laboratory analysis confirmed product contains undeclared sildenafil.

33 M - - -- Gel-Like Soft Candy in Containers or on Sticks
Date Published: 10/17/2016

Desc: Ryukakusan Herbal Drops (All Flavors)
Notes: FDA laboratory analysis confirmed product contains undeclared sildenafil

54 F - - -- Herbal & Botanicals(other than teas)
Date Published: 10/17/2016

Desc: Ryukakusan Herbal Drops (All Flavors)
Notes: FDA laboratory analysis confirmed product contains undeclared sildenafil

54 K - - -- Herbal & Botanicals(other than teas) II
Date Published: 10/17/2016

Desc: Ryukakusan Herbal Drops (All Flavors)
Notes: FDA laboratory analysis confirmed product contains undeclared sildenafil. ;

54 Y - - -- Vit/Min/Prot/Unconv Diet Spec N.E.C.
Date Published: 10/17/2016

Desc: Ryukakusan Herbal Drops (All Flavors)
Notes: FDA laboratory analysis confirmed product contains undeclared sildenafil. ;

65 P - - 02 Sildenafil Citrate (Regulator)
Date Published: 10/17/2016

Desc: Ryukakusan Herbal Drops (All Flavors)
Notes: FDA laboratory analysis confirmed product contains undeclared sildenafil.

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 10/17/2016

Desc: Ryukakusan Herbal Drops (All Flavors)
Notes: FDA laboratory analysis confirmed product contains undeclared sildenafil.

Ryukakusan Co Ltd
Date Published : 10/17/2016
2 Chome 2 , Higashikanda; Tarui-Cho , Fuwa-Gun, Gifu JAPAN
33 E - - -- Hard Candy W/O Nut/Fruit
Date Published: 10/17/2016

Desc: Ryukakusan Herbal Drops (All Flavors)
Notes: FDA laboratory analysis confirmed product contains undeclared sildenafil

33 M - - -- Gel-Like Soft Candy in Containers or on Sticks
Date Published: 10/17/2016

Desc: Ryukakusan Herbal Drops (All Flavors)
Notes: FDA laboratory analysis confirmed product contains undeclared sildenafil

54 F - - -- Herbal & Botanicals(other than teas)
Date Published: 10/17/2016

Desc: Ryukakusan Herbal Drops (All Flavors)
Notes: FDA laboratory analysis confirmed product contains undeclared sildenafil

54 K - - -- Herbal & Botanicals(other than teas) II
Date Published: 10/17/2016

Desc: Ryukakusan Herbal Drops (All Flavors)
Notes: FDA laboratory analysis confirmed product contains undeclared sildenafil

54 Y - - -- Vit/Min/Prot/Unconv Diet Spec N.E.C.
Date Published: 10/17/2016

Desc: Ryukakusan Herbal Drops (All Flavors)
Notes: FDA laboratory analysis confirmed product contains undeclared sildenafil.

65 P - - 02 Sildenafil Citrate (Regulator)
Date Published: 10/17/2016

Desc: Ryukakusan Herbal Drops (All Flavors)
Notes: FDA laboratory analysis confirmed product contains undeclared sildenafil.

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 10/17/2016

Desc: Ryukakusan Herbal Drops (All Flavors)
Notes: FDA laboratory analysis confirmed product contains undeclared sildenafil

Ryukakusan Co. Ltd.
Date Published : 10/17/2016
1460-3 Azamitodai , Mito; Tako-Machi , Katori-Gun, JAPAN
33 E - - -- Hard Candy W/O Nut/Fruit
Date Published: 10/17/2016

Desc: Ryukakusan Herbal Drops (All Flavors)
Notes: FDA laboratory analysis confirmed product contains undeclared sildenafil.

33 M - - -- Gel-Like Soft Candy in Containers or on Sticks
Date Published: 10/17/2016

Desc: Ryukakusan Herbal Drops (All Flavors)
Notes: FDA laboratory analysis confirmed product contains undeclared sildenafil.

54 F - - -- Herbal & Botanicals(other than teas)
Date Published: 10/17/2016

Desc: Ryukakusan Herbal Drops (All Flavors)
Notes: FDA laboratory analysis confirmed product contains undeclared sildenafil.

54 K - - -- Herbal & Botanicals(other than teas) II
Date Published: 10/17/2016

Desc: Ryukakusan Herbal Drops (All Flavors)
Notes: FDA laboratory analysis confirmed product contains undeclared sildenafil.

54 Y - - -- Vit/Min/Prot/Unconv Diet Spec N.E.C.
Date Published: 10/17/2016

Desc: Ryukakusan Herbal Drops (All Flavors)
Notes: FDA laboratory analysis confirmed product contains undeclared sildenafil

65 P - - 02 Sildenafil Citrate (Regulator)
Date Published: 10/17/2016

Desc: Ryukakusan Herbal Drops (All Flavors)
Notes: FDA laboratory analysis confirmed product contains undeclared sildenafil

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 10/17/2016

Desc: Ryukakusan Herbal Drops (All Flavors)
Notes: FDA laboratory analysis confirmed product contains undeclared sildenafil


KOREA, REPUBLIC OF (SOUTH)


Dae Han Corporation
Date Published : 06/30/2015
703 Sungwoo Starus, 16 Gumi-Ro, , Bundang-Gu , Seongnam-si, KYONGGi KOREA, REPUBLIC OF (SOUTH)
54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 06/30/2015

Desc: Power Khan Pills
Notes: Undeclared Sulfoaildenafil and Acetildenafil


MALAYSIA


Achlim Trading Sdn Bhd
Date Published : 09/07/2016
1-113a Plaza Idaman , Jalan Gombak, Medan Idaman , Kuala Lumpur, Wilayah Persekutuan MALAYSIA
36 C - - 04 Honey
Date Published: 07/10/2017

Desc: KINGDOM HONEY FOR HER
Notes: Product contains Tadalafil per FDA analysis

36 C - - 04 Honey
Date Published: 07/10/2017

Desc: KINGDOM ROYAL HONEY
Notes: Product contains Tadalafil per FDA analysis

36 C - - 04 Honey
Date Published: 07/10/2017

Desc: KINGDOM HONEY FOR HIM
Notes: Product contains Tadalafil per FDA analysis

36 C - - 04 Honey
Date Published: 06/29/2017

Desc: Royal Honey VIP
Notes: Product contains Tadalafil per FDA analysis

36 C - - 99 Honey, N.E.C.
Date Published: 06/29/2017

Desc: Royal Honey VIP
Notes: Product contains Tadalafil per FDA analysis

54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 09/07/2016

Desc: Etumax Royal Honey For Him
Notes: Problem(s); FDA laboratory analysis confirmed product contains undeclared tadalafil.

54 Y - - 10 Royal Jelly (Vit/Min/Protein/Unconventional Dietary Spec for Human/Animal, N.E.C.)
Date Published: 06/29/2017

Desc: Royal Honey VIP
Notes: Product contains Tadalafil per FDA analysis

54 Y - - 10 Royal Jelly (Vit/Min/Protein/Unconventional Dietary Spec for Human/Animal, N.E.C.)
Date Published: 07/10/2017

Desc: KINGDOM HONEY FOR HER
Notes: Product contains Tadalafil per FDA analysis

54 Y - - 10 Royal Jelly (Vit/Min/Protein/Unconventional Dietary Spec for Human/Animal, N.E.C.)
Date Published: 07/10/2017

Desc: KINGDOM ROYAL HONEY
Notes: Product contains Tadalafil per FDA analysis

54 Y - - 10 Royal Jelly (Vit/Min/Protein/Unconventional Dietary Spec for Human/Animal, N.E.C.)
Date Published: 07/10/2017

Desc: KINGDOM HONEY FOR HIM
Notes: Product contains Tadalafil per FDA analysis

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 07/10/2017

Desc: KINGDOM HONEY FOR HER
Notes: Product contains Tadalafil per FDA analysis

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 06/29/2017

Desc: Royal Honey VIP
Notes: Product contains Tadalafil per FDA analysis

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 09/07/2016

Desc: Etumax Royal Honey For Him
Notes: Problem(s); FDA laboratory analysis confirmed product contains undeclared tadalafil.

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 07/10/2017

Desc: KINGDOM HONEY FOR HIM
Notes: Product contains Tadalafil per FDA analysis

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 07/10/2017

Desc: KINGDOM ROYAL HONEY
Notes: Product contains Tadalafil per FDA analysis

66 S - - 51 Tadalafil
Date Published: 09/07/2016

Desc: Etumax Royal Honey For Him
Notes: Problem(s); FDA laboratory analysis confirmed product contains undeclared tadalafil.

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 07/10/2017

Desc: KINGDOM HONEY FOR HER
Notes: Product contains Tadalafil per FDA analysis

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 07/10/2017

Desc: KINGDOM ROYAL HONEY
Notes: Product contains Tadalafil per FDA analysis

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 07/10/2017

Desc: KINGDOM HONEY FOR HIM
Notes: Product contains Tadalafil per FDA analysis

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 09/07/2016

Desc: Etumax Royal Honey For Him
Notes: Problem(s); FDA laboratory analysis confirmed product contains undeclared tadalafil.

Biotivity SDN BHD
Date Published : 06/29/2017
Lot 6384 , Jalan Gelung Pepuyu , Bota, Perak MALAYSIA
36 C - - 04 Honey
Date Published: 06/29/2017

Desc: Royal Honey VIP
Notes: Product contains Tadalafil per FDA analysis

36 C - - 99 Honey, N.E.C.
Date Published: 06/29/2017

Desc: Royal Honey VIP
Notes: Product contains Tadalafil per FDA analysis

54 Y - - 10 Royal Jelly (Vit/Min/Protein/Unconventional Dietary Spec for Human/Animal, N.E.C.)
Date Published: 06/29/2017

Desc: Royal Honey VIP
Notes: Product contains Tadalafil per FDA analysis

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 06/29/2017

Desc: Royal Honey VIP
Notes: Product contains Tadalafil per FDA analysis

CAVERFLO TEXAS TRADING
Date Published : 09/26/2017
117 Lorong Bunga Raya 5 , Sungai Petani, Kedah MALAYSIA
31 A - - -- Coffee
Date Published: 09/26/2017

Desc: CaverFlo Natural Herbal Coffee
Notes: FDA laboratory analysis confirmed product contains undeclared Desmethyl Carbodenafil; an analogue of Sildenafil

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 09/26/2017

Desc: CaverFlo Natural Herbal Coffee
Notes: FDA laboratory analysis confirmed product contains undeclared Desmethyl Carbodenafil; an analogue of Sildenafil

65 P - - 02 Sildenafil Citrate (Regulator)
Date Published: 09/26/2017

Desc: CaverFlo Natural Herbal Coffee
Notes: FDA laboratory analysis confirmed product contains undeclared Desmethyl Carbodenafil; an analogue of Sildenafil

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 09/26/2017

Desc: CaverFlo Natural Herbal Coffee
Notes: FDA laboratory analysis confirmed product contains undeclared Desmethyl Carbodenafil; an analogue of Sildenafil

DRS SECRET WORLDWIDE MANUFACTURING SDN BHD
Date Published : 05/19/2016
No 42 2nd Jalan Todak 2 , Bandar Seberang Jaya , Perai, Pulau Pinang MALAYSIA
31 A - - -- Coffee
Date Published: 05/19/2016

Desc: DR's SECRET BIO HERBS COFFEE
Notes: Problem(s); Product contains Tadalafil per FDA analysis.

36 C - - 04 Honey
Date Published: 05/24/2016

Desc: Royal King Honey (Food Supplement)
Notes: Product was found to contain undeclared Thiosildenafil and Hydroxythiohomosildenafil.

36 C - - 04 Honey
Date Published: 05/24/2016

Desc: Mens Bio Honey Malaysia Recipe
Notes: Product was found to contain undeclared Thiosildenafil and Hydroxythiohomosildenafil

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 05/24/2016

Desc: Mens Bio Honey Malaysia Recipe
Notes: Product was found to contain undeclared Thiosildenafil and Hydroxythiohomosildenafil

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 05/24/2016

Desc: Royal King Honey (Food Supplement)
Notes: Product was found to contain undeclared Thiosildenafil and Hydroxythiohomosildenafil.

65 P - - 02 Sildenafil Citrate (Regulator)
Date Published: 05/24/2016

Desc: Mens Bio Honey Malaysia Recipe
Notes: Product was found to contain undeclared Thiosildenafil and Hydroxythiohomosildenafil

65 P - - 02 Sildenafil Citrate (Regulator)
Date Published: 05/24/2016

Desc: Royal King Honey (Food Supplement)
Notes: Product was found to contain undeclared Thiosildenafil and Hydroxythiohomosildenafil

66 S - - 51 Tadalafil
Date Published: 05/19/2016

Desc: DR's SECRET BIO HERBS COFFEE
Notes: Problem(s); Product contains Tadalafil per FDA analysis.

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 05/24/2016

Desc: Mens Bio Honey Malaysia Recipe
Notes: Product was found to contain undeclared Thiosildenafil and Hydroxythiohomosildenafil

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 05/24/2016

Desc: Royal King Honey (Food Supplement)
Notes: Product was found to contain undeclared Thiosildenafil and Hydroxythiohomosildenafil

Dose Vital Manufacturing SDN BHD
Date Published : 06/08/2018
No. 8a Jalan Kelang Lama , Kuala Lumpur, Wilayah Persekutuan MALAYSIA
36 C - - 04 Honey
Date Published: 06/08/2018

Desc: Vital Honey with Caviar and Tongkat All Powder Dietary Supplement
Notes: Product was found to contain undeclared Tadalafil.

36 C - - 99 Honey, N.E.C.
Date Published: 06/08/2018

Desc: Vital Honey with Caviar and Tongkat All Powder Dietary Supplement
Notes: Product was found to contain undeclared Tadalafil.

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 06/08/2018

Desc: Vital Honey with Caviar and Tongkat All Powder Dietary Supplement
Notes: Product was found to contain undeclared Tadalafil

66 Y - - 99 Exhibits - Other Drug Related Items N.E.C.
Date Published: 06/08/2018

Desc: Vital Honey with Caviar and Tongkat All Powder Dietary Supplement
Notes: Product was found to contain undeclared Tadalafil

Dr Foerster (M) Sdn Bhd
Date Published : 11/27/2018
No. 95 Jalan Nilam 1/2 , Shah Alam, Selangor MALAYSIA
54 - - - -- Vit/Min/Prot/Unconv Diet(Human/Animal)
Date Published: 11/27/2018

Desc: Ultra Detox Capsules
Notes: FDA laboratory analysis confirmed product contains undeclared tadalafil

66 S - - 51 Tadalafil
Date Published: 11/27/2018

Desc: Ultra Detox Capsules
Notes: FDA laboratory analysis confirmed product contains undeclared tadalafil

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 11/27/2018

Desc: Ultra Detox Capsules
Notes: FDA laboratory analysis confirmed product contains undeclared tadalafil

Drs Secret Worldwide Manufacturing Sdn Bhd
Date Published : 05/19/2016
No. 12 Jalan Perusahaan Sungai Lokan 3 , Butterworth, Pulau Pinang MALAYSIA
31 A - - -- Coffee
Date Published: 05/19/2016

Desc: DR's SECRET BIO HERBS COFFEE
Notes: Problem(s); Product contains Tadalafil per FDA analysis.

66 S - - 51 Tadalafil
Date Published: 05/19/2016

Desc: DR's SECRET BIO HERBS COFFEE
Notes: Problem(s); Product contains Tadalafil per FDA analysis.

HERAMIOS SDN BHD
Date Published : 06/08/2018
5-17 Jalan Pju 1a/7 , Petaling Jaya, Selangor MALAYSIA
36 C - - 04 Honey
Date Published: 06/08/2018

Desc: Vital Honey with Caviar and Tongkat All Powder Dietary Supplement
Notes: Product was found to contain undeclared Tadalafil

36 C - - 99 Honey, N.E.C.
Date Published: 06/08/2018

Desc: Vital Honey with Caviar and Tongkat All Powder Dietary Supplement
Notes: Product was found to contain undeclared Tadalafil

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 06/08/2018

Desc: Vital Honey with Caviar and Tongkat All Powder Dietary Supplement
Notes: Product was found to contain undeclared Tadalafil.

66 Y - - 99 Exhibits - Other Drug Related Items N.E.C.
Date Published: 06/08/2018

Desc: Vital Honey with Caviar and Tongkat All Powder Dietary Supplement
Notes: Product was found to contain undeclared Tadalafil.

KINGDOM HONEY SDN BHD
Date Published : 07/10/2017
113A Jalan Bukit Idaman , Kuala Lumpur, Wilayah Persekutuan MALAYSIA
36 C - - 04 Honey
Date Published: 07/10/2017

Desc: KINGDOM ROYAL HONEY
Notes: Product contains Tadalafil per FDA analysis

36 C - - 04 Honey
Date Published: 07/10/2017

Desc: KINGDOM HONEY FOR HIM
Notes: Product contains Tadalafil per FDA analysis

36 C - - 04 Honey
Date Published: 07/10/2017

Desc: KINGDOM HONEY FOR HER
Notes: Product contains Tadalafil per FDA analysis

54 Y - - 10 Royal Jelly (Vit/Min/Protein/Unconventional Dietary Spec for Human/Animal, N.E.C.)
Date Published: 07/10/2017

Desc: KINGDOM HONEY FOR HER
Notes: Product contains Tadalafil per FDA analysis

54 Y - - 10 Royal Jelly (Vit/Min/Protein/Unconventional Dietary Spec for Human/Animal, N.E.C.)
Date Published: 07/10/2017

Desc: KINGDOM HONEY FOR HIM
Notes: Product contains Tadalafil per FDA analysis

54 Y - - 10 Royal Jelly (Vit/Min/Protein/Unconventional Dietary Spec for Human/Animal, N.E.C.)
Date Published: 07/10/2017

Desc: KINGDOM ROYAL HONEY
Notes: Product contains Tadalafil per FDA analysis

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 07/10/2017

Desc: KINGDOM HONEY FOR HIM
Notes: Product contains Tadalafil per FDA analysis

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 07/10/2017

Desc: KINGDOM ROYAL HONEY
Notes: Product contains Tadalafil per FDA analysis

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 07/10/2017

Desc: KINGDOM HONEY FOR HER
Notes: Product contains Tadalafil per FDA analysis

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 07/10/2017

Desc: KINGDOM HONEY FOR HIM
Notes: Product contains Tadalafil per FDA analysis

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 07/10/2017

Desc: KINGDOM ROYAL HONEY
Notes: Product contains Tadalafil per FDA analysis

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 07/10/2017

Desc: KINGDOM HONEY FOR HER
Notes: Product contains Tadalafil per FDA analysis

Medcare Smart SDN BHD
Date Published : 09/22/2016
21-1 Jalan kg Pandan , Taman Maluri 55100 , Kuala, Lampur MALAYSIA
36 C - - 04 Honey
Date Published: 09/22/2016

Desc: Golden Royal Honey
Notes: Product was found to contain undeclared Tadalafil

66 S - - 51 Tadalafil
Date Published: 09/22/2016

Desc: Golden Royal Honey
Notes: Product was found to contain undeclared Tadalafil

NATURAL ELIXIRS SDN BHD
Date Published : 11/27/2018
No 17 Jalan Selat Selat , Pelabuhan Klang, MALAYSIA
54 - - - -- Vit/Min/Prot/Unconv Diet(Human/Animal)
Date Published: 11/27/2018

Desc: Ultra Detox Capsules
Notes: FDA laboratory analysis confirmed product contains undeclared tadalafil

66 S - - 51 Tadalafil
Date Published: 11/27/2018

Desc: Ultra Detox Capsules
Notes: FDA laboratory analysis confirmed product contains undeclared tadalafil

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 11/27/2018

Desc: Ultra Detox Capsules
Notes: FDA laboratory analysis confirmed product contains undeclared tadalafil

Natural Elixirs
Date Published : 05/04/2017
6 Jalan Jasmin , Selangor, MALAYSIA
54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 05/04/2017

Desc: GRANDE PLATINUM - BINDII
Notes: Product was found to contain undeclared Tadalafil.

54 - - - -- Vit/Min/Prot/Unconv Diet(Human/Animal)
Date Published: 11/27/2018

Desc: Ultra Detox Capsules
Notes: FDA laboratory analysis confirmed product contains undeclared tadalafil.

66 S - - 51 Tadalafil
Date Published: 11/27/2018

Desc: Ultra Detox Capsules
Notes: FDA laboratory analysis confirmed product contains undeclared tadalafil

66 S - - 51 Tadalafil
Date Published: 05/04/2017

Desc: GRANDE PLATINUM - BINDII
Notes: Product was found to contain undeclared Tadalafil.

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 11/27/2018

Desc: Ultra Detox Capsules
Notes: FDA laboratory analysis confirmed product contains undeclared tadalafil

Worldgate Vision Beverage Sdn Bhd
Date Published : 08/05/2016
95 Jalan Enggang , Sungai Petani, Kedah MALAYSIA
31 E - - 06 Herbal Coffee (Blend of herbs, grains, fruits and nuts)
Date Published: 09/20/2016

Desc: STIFF BULL HERBAL COFFEE
Notes: Product was found to contain undeclared Desmethyl carbodenafil

31 E - - 06 Herbal Coffee (Blend of herbs, grains, fruits and nuts)
Date Published: 08/05/2016

Desc: Natural Herbs Coffee
Notes: Product was found to contain undeclared Desmethyl carbodenafil.

31 - - - -- Coffee/Tea
Date Published: 09/19/2017

Desc: Kopi Jantan Tradisional Natural Herbs Coffee
Notes: Problem(s); Product was found to contain undeclared Desmethyl Carbodenafil.

54 - - - -- Vit/Min/Prot/Unconv Diet(Human/Animal)
Date Published: 09/19/2017

Desc: Kopi Jantan Tradisional Natural Herbs Coffee
Notes: Problem(s); Product was found to contain undeclared Desmethyl Carbodenafil.

65 P - - 02 Sildenafil Citrate (Regulator)
Date Published: 09/19/2017

Desc: Kopi Jantan Tradisional Natural Herbs Coffee
Notes: Problem(s); Product was found to contain undeclared Desmethyl Carbodenafil.

65 P - - 99 Regulator N.E.C.
Date Published: 09/20/2016

Desc: STIFF BULL HERBAL COFFEE
Notes: Product was found to contain undeclared Desmethyl carbodenafil

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 08/05/2016

Desc: Natural Herbs Coffee
Notes: Product was found to contain undeclared Desmethyl carbodenafil.

Yong Fatt Vision T
Date Published : 09/19/2017
16 A431 Lorong , Sungai Petani, Kedah MALAYSIA
31 - - - -- Coffee/Tea
Date Published: 09/19/2017

Desc: Kopi Jantan Tradisional Natural Herbs Coffee
Notes: Problem(s); Product was found to contain undeclared Desmethyl Carbodenafil;                                                                                                                                                                                                      

54 F - - -- Herbal & Botanicals(other than teas)
Date Published: 09/19/2017

Desc: Kopi Jantan Tradisional Natural Herbs Coffee
Notes: Problem(s); Product was found to contain undeclared Desmethyl Carbodenafil.                                                                                                                                                                                                       

65 P - - 02 Sildenafil Citrate (Regulator)
Date Published: 09/19/2017

Desc: Kopi Jantan Tradisional Natural Herbs Coffee
Notes: Problem(s); Product was found to contain undeclared Desmethyl Carbodenafil;                                                                                                                                                                                                     

Yongfatt Vision Tr
Date Published : 09/19/2017
95 Jalan Enggang , Sungai Petani, Kedah MALAYSIA
31 - - - -- Coffee/Tea
Date Published: 09/19/2017

Desc: Kopi Jantan Tradisional Natural Herbs Coffee
Notes: Problem(s); Product was found to contain undeclared Desmethyl Carbodenafil;                                                                                                                                                                                                     

54 - - - -- Vit/Min/Prot/Unconv Diet(Human/Animal)
Date Published: 09/19/2017

Desc: Kopi Jantan Tradisional Natural Herbs Coffee
Notes: Problem(s); Product was found to contain undeclared Desmethyl Carbodenafil;                                                                                                                                                                                                     

65 P - - 02 Sildenafil Citrate (Regulator)
Date Published: 09/19/2017

Desc: Kopi Jantan Tradisional Natural Herbs Coffee
Notes: Problem(s); Product was found to contain undeclared Desmethyl Carbodenafil;                                                                                                                                                                                                     


MEXICO


GRUPO BOTANICO NAYEC SA DE CV
Date Published : 02/04/2016
Espana No 423 , Col. San Nicolas Tolentino, Iztapalapa , Ciudad De Mexico, Ciudad de Mexico MEXICO
41 B - - 99 Foods with Supplemental Nutrients Added, with or without Artifical Sweetners
Date Published: 02/04/2016

Desc: Tepezcohuite Capsules
Notes: Product was found to contain undeclared N; N- Dimethyltryptamine

54 E - - 99 Herbals & Botanical Teas, N.E.C.
Date Published: 02/04/2016

Desc: Tepezcohuite Capsules
Notes: Product was found to contain undeclared N; N- Dimethyltryptamine

54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 02/04/2016

Desc: Tepezcohuite Capsules
Notes: Product was found to contain undeclared N; N- Dimethyltryptamine

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 02/04/2016

Desc: Tepezcohuite Capsules
Notes: Product was found to contain undeclared N; N- Dimethyltryptamine

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 02/04/2016

Desc: Tepezcohuite Capsules
Notes: Product was found to contain undeclared N; N- Dimethyltryptamine

Healthy Labs S. de R. L. de C. V.
Date Published : 01/25/2018
Prolongacion Alvaro Obregon 961 , Col. Fracc Lomas De Santa Cecilia, Irapuato , Irapuato, Guanajuato MEXICO
41 B - - 99 Foods with Supplemental Nutrients Added, with or without Artifical Sweetners
Date Published: 01/25/2018

Desc: Goji-Man Mangosteen Liquid Dietary Supplement
Notes: Problem(s); Sildenafil

41 Y - - 99 Dietary Conventional Foods, N.E.C.
Date Published: 01/26/2018

Desc: Goji-Man Mangosteen Liquid Dietary Supplement
Notes: Problem(s); Sildenafil

54 A - - 90 Multiple Vitamins (MVI-12 vitamin combo) (Vitamin)
Date Published: 01/25/2018

Desc: Goji-Man Mangosteen Liquid Dietary Supplement
Notes: Problem(s); Sildenafil

54 A - - 99 Vitamin, N.E.C.
Date Published: 01/25/2018

Desc: Goji-Man Mangosteen Liquid Dietary Supplement
Notes: Problem(s); Sildenafil

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 01/25/2018

Desc: Goji-Man Mangosteen Liquid Dietary Supplement
Notes: Problem(s); Sildenafil

65 P - - 02 Sildenafil Citrate (Regulator)
Date Published: 01/25/2018

Desc: Goji-Man Mangosteen Liquid Dietary Supplement
Notes: Problem(s); Sildenafil

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 01/25/2018

Desc: Goji-Man Mangosteen Liquid Dietary Supplement
Notes: Problem(s); Sildenafil

Healthy People S de R.L. de CV
Date Published : 01/25/2018
Calle Luis Alcantara No. 674 , Col. Los Eucaliptos , Irapuato, Guanajuato MEXICO
41 B - - 99 Foods with Supplemental Nutrients Added, with or without Artifical Sweetners
Date Published: 01/25/2018

Desc: Goji-Man Mangosteen Liquid Dietary Supplement
Notes: Problem(s); Sildenafil

41 Y - - 99 Dietary Conventional Foods, N.E.C.
Date Published: 01/25/2018

Desc: Goji-Man Mangosteen Liquid Dietary Supplement
Notes: Problem(s); Sildenafil

54 A - - 90 Multiple Vitamins (MVI-12 vitamin combo) (Vitamin)
Date Published: 01/25/2018

Desc: Goji-Man Mangosteen Liquid Dietary Supplement
Notes: Problem(s); Sildenafil

54 A - - 99 Vitamin, N.E.C.
Date Published: 01/25/2018

Desc: Goji-Man Mangosteen Liquid Dietary Supplement
Notes: Problem(s); Sildenafil

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 01/25/2018

Desc: Goji-Man Mangosteen Liquid Dietary Supplement
Notes: Problem(s); Sildenafil

65 P - - 02 Sildenafil Citrate (Regulator)
Date Published: 01/25/2018

Desc: Goji-Man Mangosteen Liquid Dietary Supplement
Notes: Problem(s); Sildenafil

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 01/25/2018

Desc: Goji-Man Mangosteen Liquid Dietary Supplement
Notes: Problem(s); Sildenafil

Herbolaris Internacional
Date Published : 01/24/2018
Calle Los Robles 122 , Col. Parques De Zapopan, Zapopan , Zapopan, Jalisco MEXICO
41 B - - 99 Foods with Supplemental Nutrients Added, with or without Artifical Sweetners
Date Published: 01/24/2018

Desc: CBC Dietary Supplement
Notes: Problem(s); Product was found to contain undeclared Norepinephrine

41 Y - - 99 Dietary Conventional Foods, N.E.C.
Date Published: 01/24/2018

Desc: CBC Dietary Supplement
Notes: Problem(s); Product was found to contain undeclared Norepinephrine

54 E - - 99 Herbals & Botanical Teas, N.E.C.
Date Published: 01/24/2018

Desc: CBC Dietary Supplement
Notes: Problem(s); Product was found to contain undeclared Norepinephrine

54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 01/24/2018

Desc: CBC Dietary Supplement
Notes: Problem(s); Product was found to contain undeclared Norepinephrine

54 K - - 08 Aloe (Herbal and Botanical (not teas) II (continued))
Date Published: 01/24/2018

Desc: CBC Dietary Supplement
Notes: Problem(s); Product was found to contain undeclared Norepinephrine

54 Y - - 09 Germanium (Vit/Min/Protein/Unconventional Dietary Spec for Human/Animal, N.E.C.)
Date Published: 01/24/2018

Desc: CBC Dietary Supplement
Notes: Problem(s); Product was found to contain undeclared Norepinephrine

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 01/24/2018

Desc: CBC Dietary Supplement
Notes: Problem(s); Product was found to contain undeclared Norepinephrine

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 01/24/2018

Desc: CBC Dietary Supplement
Notes: Problem(s); Product was found to contain undeclared Norepinephrine


TAIWAN


Sun Ten Natureceutica Co., Ltd.
Date Published : 02/17/2016
3F, No. 205-1, Sec. 3, Beixin Rd., , Xindian Dist., , New Taipei City, TW-TPQ TAIWAN
54 E - - 99 Herbals & Botanical Teas, N.E.C.
Date Published: 02/17/2016

Desc: Red Yeast Rice
Notes: Product contains lovastatin per FDA analysis.


THAILAND


H.C. Herb Club Laboratory
Date Published : 08/02/2018
91/1 Bangparok , Muang , Pathumthani, THAILAND
54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 08/02/2018

Desc: PAYA Dietary Supplement Product
Notes: Problem(s); Sibutramine

60 R - - 19 Sibutramine HCL Monohydrate (Anorexic)
Date Published: 08/02/2018

Desc: PAYA Dietary Supplement Product
Notes: Problem(s); Sibutramine


TURKEY


GOKCE BITKISEL URUNLER-UFUK GOKCE
Date Published : 01/16/2019
Cevizli Mah. , Bayraktar Sokak A Blok No:5-7 17 , Kartal, Istanbul TURKEY
36 C - - 04 Honey
Date Published: 01/16/2019

Desc: Secret Miracle Honey
Notes: FDA laboratory analysis confirmed product contains undeclared Sildenafil.

36 C - - 99 Honey, N.E.C.
Date Published: 01/16/2019

Desc: Secret Miracle Honey
Notes: FDA laboratory analysis confirmed product contains undeclared Sildenafil.

54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 01/16/2019

Desc: Secret Miracle Honey
Notes: FDA laboratory analysis confirmed product contains undeclared Sildenafil.

54 - - - -- Vit/Min/Prot/Unconv Diet(Human/Animal)
Date Published: 01/16/2019

Notes: FDA laboratory analysis confirmed product contains undeclared Sildenafil.

65 P - - 02 Sildenafil Citrate (Regulator)
Date Published: 01/16/2019

Desc: Secret Miracle Honey
Notes: FDA laboratory analysis confirmed product contains undeclared Sildenafil.

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 01/16/2019

Desc: Secret Miracle Honey
Notes: FDA laboratory analysis confirmed product contains undeclared Sildenafil.

HAN ITHALAT IHRACAT VE DANISMANLIK LTD STI
Date Published : 02/13/2019
FEVZI CAKMAK MAH ZONDULDAK SOK NO:22A , PENDIK, ISTANBUL TURKEY
02 - - - -- Whole Grain/Milled Grain Prod/Starch
Date Published: 02/13/2019

Notes: Secret Miracle Honey For Women; Note: FDA laboratory analysis confirmed product contains undeclared tadalafil and sildenafil.; Leopard Cupid Honey; Note: FDA laboratory analysis confirmed product contains undeclared sildenafil.; Secret Miracle Honey For Men; Note: FDA laboratory analysis confirmed product contains undeclared sildenafil.

03 - - - -- Bakery Prod/Dough/Mix/Icing
Date Published: 02/13/2019

Notes: Secret Miracle Honey For Women; Note: FDA laboratory analysis confirmed product contains undeclared tadalafil and sildenafil.; Leopard Cupid Honey; Note: FDA laboratory analysis confirmed product contains undeclared sildenafil.; Secret Miracle Honey For Men; Note: FDA laboratory analysis confirmed product contains undeclared sildenafil.

04 - - - -- Macaroni/Noodle Prod
Date Published: 02/13/2019

Notes: Secret Miracle Honey For Women; Note: FDA laboratory analysis confirmed product contains undeclared tadalafil and sildenafil.; Leopard Cupid Honey; Note: FDA laboratory analysis confirmed product contains undeclared sildenafil.; Secret Miracle Honey For Men; Note: FDA laboratory analysis confirmed product contains undeclared sildenafil.

05 - - - -- Cereal Prep/Breakfast Food
Date Published: 02/13/2019

Notes: Secret Miracle Honey For Women; Note: FDA laboratory analysis confirmed product contains undeclared tadalafil and sildenafil.; Leopard Cupid Honey; Note: FDA laboratory analysis confirmed product contains undeclared sildenafil.; Secret Miracle Honey For Men; Note: FDA laboratory analysis confirmed product contains undeclared sildenafil.

07 - - - -- Snack Food Item
Date Published: 02/13/2019

Notes: Secret Miracle Honey For Women; Note: FDA laboratory analysis confirmed product contains undeclared tadalafil and sildenafil.; Leopard Cupid Honey; Note: FDA laboratory analysis confirmed product contains undeclared sildenafil.; Secret Miracle Honey For Men; Note: FDA laboratory analysis confirmed product contains undeclared sildenafil.

09 - - - -- Milk/Butter/Dried Milk Prod
Date Published: 02/13/2019

Notes: Secret Miracle Honey For Women; Note: FDA laboratory analysis confirmed product contains undeclared tadalafil and sildenafil.; Leopard Cupid Honey; Note: FDA laboratory analysis confirmed product contains undeclared sildenafil.; Secret Miracle Honey For Men; Note: FDA laboratory analysis confirmed product contains undeclared sildenafil.

12 - - - -- Cheese/Cheese Prod
Date Published: 02/13/2019

Notes: Secret Miracle Honey For Women; Note: FDA laboratory analysis confirmed product contains undeclared tadalafil and sildenafil.; Leopard Cupid Honey; Note: FDA laboratory analysis confirmed product contains undeclared sildenafil.; Secret Miracle Honey For Men; Note: FDA laboratory analysis confirmed product contains undeclared sildenafil.

13 - - - -- Ice Cream Prod
Date Published: 02/13/2019

Notes: Secret Miracle Honey For Women; Note: FDA laboratory analysis confirmed product contains undeclared tadalafil and sildenafil.; Leopard Cupid Honey; Note: FDA laboratory analysis confirmed product contains undeclared sildenafil.; Secret Miracle Honey For Men; Note: FDA laboratory analysis confirmed product contains undeclared sildenafil.

14 - - - -- Filled Milk/Imit Milk Prod
Date Published: 02/13/2019

Notes: Secret Miracle Honey For Women; Note: FDA laboratory analysis confirmed product contains undeclared tadalafil and sildenafil.; Leopard Cupid Honey; Note: FDA laboratory analysis confirmed product contains undeclared sildenafil.; Secret Miracle Honey For Men; Note: FDA laboratory analysis confirmed product contains undeclared sildenafil.

15 - - - -- Egg/Egg Prod
Date Published: 02/13/2019

Notes: Secret Miracle Honey For Women; Note: FDA laboratory analysis confirmed product contains undeclared tadalafil and sildenafil.; Leopard Cupid Honey; Note: FDA laboratory analysis confirmed product contains undeclared sildenafil.; Secret Miracle Honey For Men; Note: FDA laboratory analysis confirmed product contains undeclared sildenafil.

16 - - - -- Fishery/Seafood Prod
Date Published: 02/13/2019

Notes: Secret Miracle Honey For Women; Note: FDA laboratory analysis confirmed product contains undeclared tadalafil and sildenafil.; Leopard Cupid Honey; Note: FDA laboratory analysis confirmed product contains undeclared sildenafil.; Secret Miracle Honey For Men; Note: FDA laboratory analysis confirmed product contains undeclared sildenafil.

17 - - - -- Meat, Meat Products and Poultry
Date Published: 02/13/2019

Notes: Secret Miracle Honey For Women; Note: FDA laboratory analysis confirmed product contains undeclared tadalafil and sildenafil.; Leopard Cupid Honey; Note: FDA laboratory analysis confirmed product contains undeclared sildenafil.; Secret Miracle Honey For Men; Note: FDA laboratory analysis confirmed product contains undeclared sildenafil.

18 - - - -- Vegetable Protein Prod
Date Published: 02/13/2019

Notes: Secret Miracle Honey For Women; Note: FDA laboratory analysis confirmed product contains undeclared tadalafil and sildenafil.; Leopard Cupid Honey; Note: FDA laboratory analysis confirmed product contains undeclared sildenafil.; Secret Miracle Honey For Men; Note: FDA laboratory analysis confirmed product contains undeclared sildenafil.

20 - - - -- Fruit/Fruit Prod
Date Published: 02/13/2019

Notes: Secret Miracle Honey For Women; Note: FDA laboratory analysis confirmed product contains undeclared tadalafil and sildenafil.; Leopard Cupid Honey; Note: FDA laboratory analysis confirmed product contains undeclared sildenafil.; Secret Miracle Honey For Men; Note: FDA laboratory analysis confirmed product contains undeclared sildenafil.

21 - - - -- Fruit/Fruit Prod
Date Published: 02/13/2019

Notes: Secret Miracle Honey For Women; Note: FDA laboratory analysis confirmed product contains undeclared tadalafil and sildenafil.; Leopard Cupid Honey; Note: FDA laboratory analysis confirmed product contains undeclared sildenafil.; Secret Miracle Honey For Men; Note: FDA laboratory analysis confirmed product contains undeclared sildenafil.

22 - - - -- Fruit/Fruit Prod
Date Published: 02/13/2019

Notes: Secret Miracle Honey For Women; Note: FDA laboratory analysis confirmed product contains undeclared tadalafil and sildenafil.; Leopard Cupid Honey; Note: FDA laboratory analysis confirmed product contains undeclared sildenafil.; Secret Miracle Honey For Men; Note: FDA laboratory analysis confirmed product contains undeclared sildenafil.

23 - - - -- Nuts/Edible Seed
Date Published: 02/13/2019

Notes: Secret Miracle Honey For Women; Note: FDA laboratory analysis confirmed product contains undeclared tadalafil and sildenafil.; Leopard Cupid Honey; Note: FDA laboratory analysis confirmed product contains undeclared sildenafil.; Secret Miracle Honey For Men; Note: FDA laboratory analysis confirmed product contains undeclared sildenafil.

24 - - - -- Vegetables/Vegetable Products
Date Published: 02/13/2019

Notes: Secret Miracle Honey For Women; Note: FDA laboratory analysis confirmed product contains undeclared tadalafil and sildenafil.; Leopard Cupid Honey; Note: FDA laboratory analysis confirmed product contains undeclared sildenafil.; Secret Miracle Honey For Men; Note: FDA laboratory analysis confirmed product contains undeclared sildenafil.

25 - - - -- Vegetables/Vegetable Products
Date Published: 02/13/2019

Notes: Secret Miracle Honey For Women; Note: FDA laboratory analysis confirmed product contains undeclared tadalafil and sildenafil.; Leopard Cupid Honey; Note: FDA laboratory analysis confirmed product contains undeclared sildenafil.; Secret Miracle Honey For Men; Note: FDA laboratory analysis confirmed product contains undeclared sildenafil.

26 - - - -- Vegetable Oils
Date Published: 02/13/2019

Notes: Secret Miracle Honey For Women; Note: FDA laboratory analysis confirmed product contains undeclared tadalafil and sildenafil.; Leopard Cupid Honey; Note: FDA laboratory analysis confirmed product contains undeclared sildenafil.; Secret Miracle Honey For Men; Note: FDA laboratory analysis confirmed product contains undeclared sildenafil.

27 - - - -- Dressing/Condiment
Date Published: 02/13/2019

Notes: Secret Miracle Honey For Women; Note: FDA laboratory analysis confirmed product contains undeclared tadalafil and sildenafil.; Leopard Cupid Honey; Note: FDA laboratory analysis confirmed product contains undeclared sildenafil.; Secret Miracle Honey For Men; Note: FDA laboratory analysis confirmed product contains undeclared sildenafil.

28 - - - -- Spices, Flavors And Salts
Date Published: 02/13/2019

Notes: Secret Miracle Honey For Women; Note: FDA laboratory analysis confirmed product contains undeclared tadalafil and sildenafil.; Leopard Cupid Honey; Note: FDA laboratory analysis confirmed product contains undeclared sildenafil.; Secret Miracle Honey For Men; Note: FDA laboratory analysis confirmed product contains undeclared sildenafil.

29 - - - -- Soft Drink/Water
Date Published: 02/13/2019

Notes: Secret Miracle Honey For Women; Note: FDA laboratory analysis confirmed product contains undeclared tadalafil and sildenafil.; Leopard Cupid Honey; Note: FDA laboratory analysis confirmed product contains undeclared sildenafil.; Secret Miracle Honey For Men; Note: FDA laboratory analysis confirmed product contains undeclared sildenafil.

30 - - - -- Beverage Bases/Conc/Nectar
Date Published: 02/13/2019

Notes: Secret Miracle Honey For Women; Note: FDA laboratory analysis confirmed product contains undeclared tadalafil and sildenafil.; Leopard Cupid Honey; Note: FDA laboratory analysis confirmed product contains undeclared sildenafil.; Secret Miracle Honey For Men; Note: FDA laboratory analysis confirmed product contains undeclared sildenafil.

31 - - - -- Coffee/Tea
Date Published: 02/13/2019

Notes: Secret Miracle Honey For Women; Note: FDA laboratory analysis confirmed product contains undeclared tadalafil and sildenafil.; Leopard Cupid Honey; Note: FDA laboratory analysis confirmed product contains undeclared sildenafil.; Secret Miracle Honey For Men; Note: FDA laboratory analysis confirmed product contains undeclared sildenafil.

32 - - - -- Alcoholic Beverage
Date Published: 02/13/2019

Notes: Secret Miracle Honey For Women; Note: FDA laboratory analysis confirmed product contains undeclared tadalafil and sildenafil.; Leopard Cupid Honey; Note: FDA laboratory analysis confirmed product contains undeclared sildenafil.; Secret Miracle Honey For Men; Note: FDA laboratory analysis confirmed product contains undeclared sildenafil.

33 - - - -- Candy W/O Choc/Special/Chew Gum
Date Published: 02/13/2019

Notes: Secret Miracle Honey For Women; Note: FDA laboratory analysis confirmed product contains undeclared tadalafil and sildenafil.; Leopard Cupid Honey; Note: FDA laboratory analysis confirmed product contains undeclared sildenafil.; Secret Miracle Honey For Men; Note: FDA laboratory analysis confirmed product contains undeclared sildenafil.

34 - - - -- Choc/Cocoa Prod
Date Published: 02/13/2019

Notes: Secret Miracle Honey For Women; Note: FDA laboratory analysis confirmed product contains undeclared tadalafil and sildenafil.; Leopard Cupid Honey; Note: FDA laboratory analysis confirmed product contains undeclared sildenafil.; Secret Miracle Honey For Men; Note: FDA laboratory analysis confirmed product contains undeclared sildenafil.

35 - - - -- Gelatin/Rennet/Pudding Mix/Pie Filling
Date Published: 02/13/2019

Notes: Secret Miracle Honey For Women; Note: FDA laboratory analysis confirmed product contains undeclared tadalafil and sildenafil.; Leopard Cupid Honey; Note: FDA laboratory analysis confirmed product contains undeclared sildenafil.; Secret Miracle Honey For Men; Note: FDA laboratory analysis confirmed product contains undeclared sildenafil.

36 - - - -- Food Sweeteners (Nutritive)
Date Published: 02/13/2019

Notes: Secret Miracle Honey For Women; Note: FDA laboratory analysis confirmed product contains undeclared tadalafil and sildenafil.; Leopard Cupid Honey; Note: FDA laboratory analysis confirmed product contains undeclared sildenafil.; Secret Miracle Honey For Men; Note: FDA laboratory analysis confirmed product contains undeclared sildenafil.

37 - - - -- Mult Food Dinner/Grav/Sauce/Special
Date Published: 02/13/2019

Notes: Secret Miracle Honey For Women; Note: FDA laboratory analysis confirmed product contains undeclared tadalafil and sildenafil.; Leopard Cupid Honey; Note: FDA laboratory analysis confirmed product contains undeclared sildenafil.; Secret Miracle Honey For Men; Note: FDA laboratory analysis confirmed product contains undeclared sildenafil.

38 - - - -- Soup
Date Published: 02/13/2019

Notes: Secret Miracle Honey For Women; Note: FDA laboratory analysis confirmed product contains undeclared tadalafil and sildenafil.; Leopard Cupid Honey; Note: FDA laboratory analysis confirmed product contains undeclared sildenafil.; Secret Miracle Honey For Men; Note: FDA laboratory analysis confirmed product contains undeclared sildenafil.

39 - - - -- Prep Salad Prod
Date Published: 02/13/2019

Notes: Secret Miracle Honey For Women; Note: FDA laboratory analysis confirmed product contains undeclared tadalafil and sildenafil.; Leopard Cupid Honey; Note: FDA laboratory analysis confirmed product contains undeclared sildenafil.; Secret Miracle Honey For Men; Note: FDA laboratory analysis confirmed product contains undeclared sildenafil.

40 A - - -- Baked Goods (Baby)
Date Published: 02/13/2019

Notes: Secret Miracle Honey For Women; Note: FDA laboratory analysis confirmed product contains undeclared tadalafil and sildenafil.; Leopard Cupid Honey; Note: FDA laboratory analysis confirmed product contains undeclared sildenafil.; Secret Miracle Honey For Men; Note: FDA laboratory analysis confirmed product contains undeclared sildenafil.

40 B - - -- Cereal (Baby)
Date Published: 02/13/2019

Notes: Secret Miracle Honey For Women; Note: FDA laboratory analysis confirmed product contains undeclared tadalafil and sildenafil.; Leopard Cupid Honey; Note: FDA laboratory analysis confirmed product contains undeclared sildenafil.; Secret Miracle Honey For Men; Note: FDA laboratory analysis confirmed product contains undeclared sildenafil.

40 D - - -- Veg (Baby)
Date Published: 02/13/2019

Notes: Secret Miracle Honey For Women; Note: FDA laboratory analysis confirmed product contains undeclared tadalafil and sildenafil.; Leopard Cupid Honey; Note: FDA laboratory analysis confirmed product contains undeclared sildenafil.; Secret Miracle Honey For Men; Note: FDA laboratory analysis confirmed product contains undeclared sildenafil.

40 E - - -- Fruit/Juice/Drink (Baby)
Date Published: 02/13/2019

Notes: Secret Miracle Honey For Women; Note: FDA laboratory analysis confirmed product contains undeclared tadalafil and sildenafil.; Leopard Cupid Honey; Note: FDA laboratory analysis confirmed product contains undeclared sildenafil.; Secret Miracle Honey For Men; Note: FDA laboratory analysis confirmed product contains undeclared sildenafil.

40 F - - -- Meat Prod/Comb Meat Dinner (Baby)
Date Published: 02/13/2019

Notes: Secret Miracle Honey For Women; Note: FDA laboratory analysis confirmed product contains undeclared tadalafil and sildenafil.; Leopard Cupid Honey; Note: FDA laboratory analysis confirmed product contains undeclared sildenafil.; Secret Miracle Honey For Men; Note: FDA laboratory analysis confirmed product contains undeclared sildenafil.

40 G - - -- Poultry Prod/Comb Poultry Dinner (Baby)
Date Published: 02/13/2019

Notes: Secret Miracle Honey For Women; Note: FDA laboratory analysis confirmed product contains undeclared tadalafil and sildenafil.; Leopard Cupid Honey; Note: FDA laboratory analysis confirmed product contains undeclared sildenafil.; Secret Miracle Honey For Men; Note: FDA laboratory analysis confirmed product contains undeclared sildenafil.

40 H - - -- High Meat Dinner/Cheese Food (Baby)
Date Published: 02/13/2019

Notes: Secret Miracle Honey For Women; Note: FDA laboratory analysis confirmed product contains undeclared tadalafil and sildenafil.; Leopard Cupid Honey; Note: FDA laboratory analysis confirmed product contains undeclared sildenafil.; Secret Miracle Honey For Men; Note: FDA laboratory analysis confirmed product contains undeclared sildenafil.

40 I - - -- Fish-Seafood Prod (Baby)
Date Published: 02/13/2019

Notes: Secret Miracle Honey For Women; Note: FDA laboratory analysis confirmed product contains undeclared tadalafil and sildenafil.; Leopard Cupid Honey; Note: FDA laboratory analysis confirmed product contains undeclared sildenafil.; Secret Miracle Honey For Men; Note: FDA laboratory analysis confirmed product contains undeclared sildenafil.

40 J - - -- Egg Prod (Baby)
Date Published: 02/13/2019

Notes: Secret Miracle Honey For Women; Note: FDA laboratory analysis confirmed product contains undeclared tadalafil and sildenafil.; Leopard Cupid Honey; Note: FDA laboratory analysis confirmed product contains undeclared sildenafil.; Secret Miracle Honey For Men; Note: FDA laboratory analysis confirmed product contains undeclared sildenafil.

40 K - - -- Pudding/Custard (Baby)
Date Published: 02/13/2019

Notes: Secret Miracle Honey For Women; Note: FDA laboratory analysis confirmed product contains undeclared tadalafil and sildenafil.; Leopard Cupid Honey; Note: FDA laboratory analysis confirmed product contains undeclared sildenafil.; Secret Miracle Honey For Men; Note: FDA laboratory analysis confirmed product contains undeclared sildenafil.

40 L - - -- Soups/Soup Mix (Baby)
Date Published: 02/13/2019

Notes: Secret Miracle Honey For Women; Note: FDA laboratory analysis confirmed product contains undeclared tadalafil and sildenafil.; Leopard Cupid Honey; Note: FDA laboratory analysis confirmed product contains undeclared sildenafil.; Secret Miracle Honey For Men; Note: FDA laboratory analysis confirmed product contains undeclared sildenafil.

40 Q - - -- Pasta and Noodle Combination Dinners Without Meat
Date Published: 02/13/2019

Notes: Secret Miracle Honey For Women; Note: FDA laboratory analysis confirmed product contains undeclared tadalafil and sildenafil.; Leopard Cupid Honey; Note: FDA laboratory analysis confirmed product contains undeclared sildenafil.; Secret Miracle Honey For Men; Note: FDA laboratory analysis confirmed product contains undeclared sildenafil. .

40 X - - -- Market Basket Sampling
Date Published: 02/13/2019

Notes: Secret Miracle Honey For Women; Note: FDA laboratory analysis confirmed product contains undeclared tadalafil and sildenafil.; Leopard Cupid Honey; Note: FDA laboratory analysis confirmed product contains undeclared sildenafil.; Secret Miracle Honey For Men; Note: FDA laboratory analysis confirmed product contains undeclared sildenafil.

40 Y - - -- Baby Food N.E.C.
Date Published: 02/13/2019

Notes: Secret Miracle Honey For Women; Note: FDA laboratory analysis confirmed product contains undeclared tadalafil and sildenafil.; Leopard Cupid Honey; Note: FDA laboratory analysis confirmed product contains undeclared sildenafil.; Secret Miracle Honey For Men; Note: FDA laboratory analysis confirmed product contains undeclared sildenafil.

41 - - - -- Dietary Conv Food/Meal Replacements
Date Published: 02/13/2019

Notes: Secret Miracle Honey For Women; Note: FDA laboratory analysis confirmed product contains undeclared tadalafil and sildenafil.; Leopard Cupid Honey; Note: FDA laboratory analysis confirmed product contains undeclared sildenafil.; Secret Miracle Honey For Men; Note: FDA laboratory analysis confirmed product contains undeclared sildenafil.

42 A - - -- Whole Edible Insects (adults and immature stages)
Date Published: 02/13/2019

Notes: Secret Miracle Honey For Women; Note: FDA laboratory analysis confirmed product contains undeclared tadalafil and sildenafil.; Leopard Cupid Honey; Note: FDA laboratory analysis confirmed product contains undeclared sildenafil.; Secret Miracle Honey For Men; Note: FDA laboratory analysis confirmed product contains undeclared sildenafil.

42 B - - -- Milled Edible Insect Products
Date Published: 02/13/2019

Notes: Secret Miracle Honey For Women; Note: FDA laboratory analysis confirmed product contains undeclared tadalafil and sildenafil.; Leopard Cupid Honey; Note: FDA laboratory analysis confirmed product contains undeclared sildenafil.; Secret Miracle Honey For Men; Note: FDA laboratory analysis confirmed product contains undeclared sildenafil.

42 C - - -- Edible Insect Bars
Date Published: 02/13/2019

Notes: Secret Miracle Honey For Women; Note: FDA laboratory analysis confirmed product contains undeclared tadalafil and sildenafil.; Leopard Cupid Honey; Note: FDA laboratory analysis confirmed product contains undeclared sildenafil.; Secret Miracle Honey For Men; Note: FDA laboratory analysis confirmed product contains undeclared sildenafil.

42 D - - -- Edible Insect Bakery Products
Date Published: 02/13/2019

Notes: Secret Miracle Honey For Women; Note: FDA laboratory analysis confirmed product contains undeclared tadalafil and sildenafil.; Leopard Cupid Honey; Note: FDA laboratory analysis confirmed product contains undeclared sildenafil.; Secret Miracle Honey For Men; Note: FDA laboratory analysis confirmed product contains undeclared sildenafil.

42 E - - -- Edible Insect Candy With Chocolate
Date Published: 02/13/2019

Notes: Secret Miracle Honey For Women; Note: FDA laboratory analysis confirmed product contains undeclared tadalafil and sildenafil.; Leopard Cupid Honey; Note: FDA laboratory analysis confirmed product contains undeclared sildenafil.; Secret Miracle Honey For Men; Note: FDA laboratory analysis confirmed product contains undeclared sildenafil.

42 F - - -- Edible Insect Candy Without Chocolate
Date Published: 02/13/2019

Notes: Secret Miracle Honey For Women; Note: FDA laboratory analysis confirmed product contains undeclared tadalafil and sildenafil.; Leopard Cupid Honey; Note: FDA laboratory analysis confirmed product contains undeclared sildenafil.; Secret Miracle Honey For Men; Note: FDA laboratory analysis confirmed product contains undeclared sildenafil.

42 G - - -- Edible Insect Capsules
Date Published: 02/13/2019

Notes: Secret Miracle Honey For Women; Note: FDA laboratory analysis confirmed product contains undeclared tadalafil and sildenafil.; Leopard Cupid Honey; Note: FDA laboratory analysis confirmed product contains undeclared sildenafil.; Secret Miracle Honey For Men; Note: FDA laboratory analysis confirmed product contains undeclared sildenafil.

42 H - - -- Edible Insect Granola or Trail Mix
Date Published: 02/13/2019

Notes: Secret Miracle Honey For Women; Note: FDA laboratory analysis confirmed product contains undeclared tadalafil and sildenafil.; Leopard Cupid Honey; Note: FDA laboratory analysis confirmed product contains undeclared sildenafil.; Secret Miracle Honey For Men; Note: FDA laboratory analysis confirmed product contains undeclared sildenafil.

42 I - - -- Edible Insect Jerky
Date Published: 02/13/2019

Notes: Secret Miracle Honey For Women; Note: FDA laboratory analysis confirmed product contains undeclared tadalafil and sildenafil.; Leopard Cupid Honey; Note: FDA laboratory analysis confirmed product contains undeclared sildenafil.; Secret Miracle Honey For Men; Note: FDA laboratory analysis confirmed product contains undeclared sildenafil.

42 J - - -- Edible Insect Ice Cream and Related Products
Date Published: 02/13/2019

Notes: Secret Miracle Honey For Women; Note: FDA laboratory analysis confirmed product contains undeclared tadalafil and sildenafil.; Leopard Cupid Honey; Note: FDA laboratory analysis confirmed product contains undeclared sildenafil.; Secret Miracle Honey For Men; Note: FDA laboratory analysis confirmed product contains undeclared sildenafil.

42 K - - -- Edible Insect Oils
Date Published: 02/13/2019

Notes: Secret Miracle Honey For Women; Note: FDA laboratory analysis confirmed product contains undeclared tadalafil and sildenafil.; Leopard Cupid Honey; Note: FDA laboratory analysis confirmed product contains undeclared sildenafil.; Secret Miracle Honey For Men; Note: FDA laboratory analysis confirmed product contains undeclared sildenafil.

42 L - - -- Edible Insect Smoothies
Date Published: 02/13/2019

Notes: Secret Miracle Honey For Women; Note: FDA laboratory analysis confirmed product contains undeclared tadalafil and sildenafil.; Leopard Cupid Honey; Note: FDA laboratory analysis confirmed product contains undeclared sildenafil.; Secret Miracle Honey For Men; Note: FDA laboratory analysis confirmed product contains undeclared sildenafil.

42 M - - -- Edible Insect Soups
Date Published: 02/13/2019

Notes: Secret Miracle Honey For Women; Note: FDA laboratory analysis confirmed product contains undeclared tadalafil and sildenafil.; Leopard Cupid Honey; Note: FDA laboratory analysis confirmed product contains undeclared sildenafil.; Secret Miracle Honey For Men; Note: FDA laboratory analysis confirmed product contains undeclared sildenafil.

42 N - - -- Edible Insect Spreads And Pastes
Date Published: 02/13/2019

Notes: Secret Miracle Honey For Women; Note: FDA laboratory analysis confirmed product contains undeclared tadalafil and sildenafil.; Leopard Cupid Honey; Note: FDA laboratory analysis confirmed product contains undeclared sildenafil.; Secret Miracle Honey For Men; Note: FDA laboratory analysis confirmed product contains undeclared sildenafil.

42 O - - -- Edible Insect Beverages
Date Published: 02/13/2019

Notes: Secret Miracle Honey For Women; Note: FDA laboratory analysis confirmed product contains undeclared tadalafil and sildenafil.; Leopard Cupid Honey; Note: FDA laboratory analysis confirmed product contains undeclared sildenafil.; Secret Miracle Honey For Men; Note: FDA laboratory analysis confirmed product contains undeclared sildenafil.

42 P - - -- Edible Insect Protein: Simulated Meats and Tofu
Date Published: 02/13/2019

Notes: Secret Miracle Honey For Women; Note: FDA laboratory analysis confirmed product contains undeclared tadalafil and sildenafil.; Leopard Cupid Honey; Note: FDA laboratory analysis confirmed product contains undeclared sildenafil.; Secret Miracle Honey For Men; Note: FDA laboratory analysis confirmed product contains undeclared sildenafil.

42 Q - - -- Edible Insect Salts and Spices
Date Published: 02/13/2019

Notes: Secret Miracle Honey For Women; Note: FDA laboratory analysis confirmed product contains undeclared tadalafil and sildenafil.; Leopard Cupid Honey; Note: FDA laboratory analysis confirmed product contains undeclared sildenafil.; Secret Miracle Honey For Men; Note: FDA laboratory analysis confirmed product contains undeclared sildenafil.

42 R - - -- Edible Insect Products N.E.C.
Date Published: 02/13/2019

Notes: Secret Miracle Honey For Women; Note: FDA laboratory analysis confirmed product contains undeclared tadalafil and sildenafil.; Leopard Cupid Honey; Note: FDA laboratory analysis confirmed product contains undeclared sildenafil.; Secret Miracle Honey For Men; Note: FDA laboratory analysis confirmed product contains undeclared sildenafil.

52 B - - 06 Corn Husks (Food Related)
Date Published: 02/13/2019

Notes: Secret Miracle Honey For Women; Note: FDA laboratory analysis confirmed product contains undeclared tadalafil and sildenafil.; Leopard Cupid Honey; Note: FDA laboratory analysis confirmed product contains undeclared sildenafil.; Secret Miracle Honey For Men; Note: FDA laboratory analysis confirmed product contains undeclared sildenafil.

52 B - - 07 Snail Shells (Food Related)
Date Published: 02/13/2019

Notes: Secret Miracle Honey For Women; Note: FDA laboratory analysis confirmed product contains undeclared tadalafil and sildenafil.; Leopard Cupid Honey; Note: FDA laboratory analysis confirmed product contains undeclared sildenafil.; Secret Miracle Honey For Men; Note: FDA laboratory analysis confirmed product contains undeclared sildenafil.

52 B - - 08 Sausage Casings, Artificial (Food Related)
Date Published: 02/13/2019

Notes: Secret Miracle Honey For Women; Note: FDA laboratory analysis confirmed product contains undeclared tadalafil and sildenafil.; Leopard Cupid Honey; Note: FDA laboratory analysis confirmed product contains undeclared sildenafil.; Secret Miracle Honey For Men; Note: FDA laboratory analysis confirmed product contains undeclared sildenafil.

52 B - - 12 Bird's Nest
Date Published: 02/13/2019

Notes: Secret Miracle Honey For Women; Note: FDA laboratory analysis confirmed product contains undeclared tadalafil and sildenafil.; Leopard Cupid Honey; Note: FDA laboratory analysis confirmed product contains undeclared sildenafil.; Secret Miracle Honey For Men; Note: FDA laboratory analysis confirmed product contains undeclared sildenafil.

52 D - - -- Live Animals
Date Published: 02/13/2019

Notes: Secret Miracle Honey For Women; Note: FDA laboratory analysis confirmed product contains undeclared tadalafil and sildenafil.; Leopard Cupid Honey; Note: FDA laboratory analysis confirmed product contains undeclared sildenafil.; Secret Miracle Honey For Men; Note: FDA laboratory analysis confirmed product contains undeclared sildenafil.

54 - - - -- Vit/Min/Prot/Unconv Diet(Human/Animal)
Date Published: 02/13/2019

Notes: Secret Miracle Honey For Women; Note: FDA laboratory analysis confirmed product contains undeclared tadalafil and sildenafil.; Leopard Cupid Honey; Note: FDA laboratory analysis confirmed product contains undeclared sildenafil.; Secret Miracle Honey For Men; Note: FDA laboratory analysis confirmed product contains undeclared sildenafil.

55 - - - -- Pharm Necess & Ctnr For Drug/Bio
Date Published: 02/13/2019

Notes: Secret Miracle Honey For Women; Note: FDA laboratory analysis confirmed product contains undeclared tadalafil and sildenafil.; Leopard Cupid Honey; Note: FDA laboratory analysis confirmed product contains undeclared sildenafil.; Secret Miracle Honey For Men; Note: FDA laboratory analysis confirmed product contains undeclared sildenafil.

60 - - - -- Human and Animal Drugs
Date Published: 02/13/2019

Notes: Secret Miracle Honey For Women; Note: FDA laboratory analysis confirmed product contains undeclared tadalafil and sildenafil.; Leopard Cupid Honey; Note: FDA laboratory analysis confirmed product contains undeclared sildenafil.; Secret Miracle Honey For Men; Note: FDA laboratory analysis confirmed product contains undeclared sildenafil.

61 - - - -- Human and Animal Drugs
Date Published: 02/13/2019

Notes: Secret Miracle Honey For Women; Note: FDA laboratory analysis confirmed product contains undeclared tadalafil and sildenafil.; Leopard Cupid Honey; Note: FDA laboratory analysis confirmed product contains undeclared sildenafil.; Secret Miracle Honey For Men; Note: FDA laboratory analysis confirmed product contains undeclared sildenafil.

62 - - - -- Human and Animal Drugs
Date Published: 02/13/2019

Notes: Secret Miracle Honey For Women; Note: FDA laboratory analysis confirmed product contains undeclared tadalafil and sildenafil.; Leopard Cupid Honey; Note: FDA laboratory analysis confirmed product contains undeclared sildenafil.; Secret Miracle Honey For Men; Note: FDA laboratory analysis confirmed product contains undeclared sildenafil.

63 - - - -- Human and Animal Drugs
Date Published: 02/13/2019

Notes: Secret Miracle Honey For Women; Note: FDA laboratory analysis confirmed product contains undeclared tadalafil and sildenafil.; Leopard Cupid Honey; Note: FDA laboratory analysis confirmed product contains undeclared sildenafil.; Secret Miracle Honey For Men; Note: FDA laboratory analysis confirmed product contains undeclared sildenafil.

64 - - - -- Human and Animal Drugs
Date Published: 02/13/2019

Notes: Secret Miracle Honey For Women; Note: FDA laboratory analysis confirmed product contains undeclared tadalafil and sildenafil.; Leopard Cupid Honey; Note: FDA laboratory analysis confirmed product contains undeclared sildenafil.; Secret Miracle Honey For Men; Note: FDA laboratory analysis confirmed product contains undeclared sildenafil.

65 - - - -- Human and Animal Drugs
Date Published: 02/13/2019

Notes: Secret Miracle Honey For Women; Note: FDA laboratory analysis confirmed product contains undeclared tadalafil and sildenafil.; Leopard Cupid Honey; Note: FDA laboratory analysis confirmed product contains undeclared sildenafil.; Secret Miracle Honey For Men; Note: FDA laboratory analysis confirmed product contains undeclared sildenafil.

66 - - - -- Human and Animal Drugs
Date Published: 02/13/2019

Notes: Secret Miracle Honey For Women; Note: FDA laboratory analysis confirmed product contains undeclared tadalafil and sildenafil.; Leopard Cupid Honey; Note: FDA laboratory analysis confirmed product contains undeclared sildenafil.; Secret Miracle Honey For Men; Note: FDA laboratory analysis confirmed product contains undeclared sildenafil.

MUBAREK DOGAL URUNLER GIDA SAN VE TIC LTD STI
Date Published : 12/28/2018
Ostim Mah , 1142 Sokak No 15/A , Yenimahalle, Ankara TURKEY
36 C - - -- Honey
Date Published: 12/28/2018

Desc: Leopard Miracle of Honey
Notes: Undeclared sildenafil and tadalafil

54 F - - -- Herbal & Botanicals(other than teas)
Date Published: 12/28/2018

Desc: Leopard Miracle of Honey
Notes: Undeclared sildenafil and tadalafil

Sahe Grup Gida Ilac Kozmetik San. Ve Tic. Ltd.
Date Published : 12/27/2018
Asagi Dudullu Mahallesi Hamz Yerlikaya Bulvari No:25/A , Umraniye , Istanbul, TURKEY
36 C - - 04 Honey
Date Published: 12/27/2018

Desc: Leopard Secret Miracle Honey
Notes: FDA laboratory analysis confirmed product contains undeclared Sildenafil.

36 C - - 99 Honey, N.E.C.
Date Published: 12/27/2018

Desc: Leopard Secret Miracle Honey
Notes: FDA laboratory analysis confirmed product contains undeclared Sildenafil.

54 - - - -- Vit/Min/Prot/Unconv Diet(Human/Animal)
Date Published: 12/27/2018

Notes: Leopard Secret Miracle Honey/ FDA laboratory analysis confirmed product contains undeclared Sildenafil.

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 12/27/2018

Desc: Leopard Secret Miracle Honey
Notes: FDA laboratory analysis confirmed product contains undeclared Sildenafil.