Import Alert 68-19

(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 # 68-19
Published Date: 04/29/2019
Type: DWPE

Import Alert Name:

"DETENTION WITHOUT PHYSICAL EXAMINATION OF UNAPPROVED NEW ANIMAL
DRUGS"

Reason for Alert:

***NOTE (02/2015): Since finished animal drugs and active pharmaceutical ingredients used in the manufacture of finished animal drugs are both defined as drugs within the meaning section 201(g)(1)(D) of the FD&C Act, CVM has indicated that the current language used in the title and portions of the narrative text of this Import Alert may lead the reader to believe that this Import Alert could also be applied to active pharmaceutical ingredients used in the manufacture of finished animal drugs. To remove confusion, this revision will revise the title and portions of the narrative text to adequately convey the scope of this alert, which is limited to finished form new animal drugs. Changes are bracketed by asterisks (***).***

This import alert represents the Agency's current guidance to FDA field personnel regarding the manufacturer(s) and/or products 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.

Reason for Alert:

Unapproved new animal drugs may present serious safety and effectiveness concerns.

***
When evidence exists that finished new animal drugs offered for import into the United States for commercial distribution are unapproved, such products would appear to be adulterated. Accordingly, the products should be considered for detention without physical examination.
***

Evidence of marketing or promotion may consist of information contained in: unapproved product being offered for import and distribution; solicitations for mail orders; press releases; internet websites; advertising materials; labeling indications of US patents or patent applications; or other public announcements directed to persons residing in the U.S.

Guidance:

***
Districts may detain without physical examination imported shipments of finished new animal drugs from manufacturers identified in the Red List to this Import Alert. Detention without physical examination of bulk active pharmaceutical ingredients [APIs] is covered under Import Alert #68-09, ‘New Bulk Animal Drug Substances'.
***

Recommendations for detention without physical examination should be forwarded to the Division of Import Operations (DIO). DIO and FDA's Center for Veterinary Medicine (CVM) will evaluate regulatory packages on a case-by-case basis.

In order to secure release of an individual entry that has been detained, the importer should provide documentation which verifies the product has a valid New Animal Drug Application (NADA) or abbreviated NADA (ANADA), conditionally approved NADA (CNADA), index listing, or Investigational New Animal Drug exemption (INAD).

In order to remove a firm from detention without physical examination, information should be provided which enables the Agency to assess whether the firm's product is in compliance with the U.S. Federal Food, Drug, and Cosmetic Act and implementing regulations and has taken the appropriate steps to ensure product has valid registrations and listings. FDA recommends a firm requesting removal from detention without physical examination provide the following information:

a. Documentation which verifies the product has a valid NADA, ANADA, CNADA, index listing or INAD.

b. Documentation showing firm's product has appropriate and valid registration and listings.

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)."

A firm, shipper or importer wishing to request removal from detention without physical examination should forward information supporting its request to FDA at the following address:

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

Or

Via email: Importalerts2@fda.hhs.gov

Requests for removal from detention without physical examination will be evaluated by DIO and CVM.

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.

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

For questions or issues involving OASIS or PREDICT screening, contact DCS's Import Compliance Systems Branch at ORAOISMDSSIMPCOMPLSYSBR@fda.hhs.gov .

Other questions may be directed to CVM, Division of Compliance, Imports Complaint Emergency Recall Team (HFV-230) at (240) 276-9200.

Product Description:

Unapproved New Animal Drugs, Misbranded Animal Drugs

Charge:

"The article is subject to refusal of admission pursuant to Section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act in that it appears to be a new animal drug that is unsafe within the meaning of Section 512(a) of the Federal Food, Drug, and Cosmetic Act as it is not the subject of an approved new animal drug application, conditionally approved new animal drug application, or index listing, and no investigational new animal drug exemption applies." [Adulteration, Section 501(a)(5)]

OASIS Charge Code – NEW VET DR

When unaccompanied by labeling which makes drug claims, but other evidence attributable to the manufacturer, owner or consignee, importer of record, or end-user exists which establishes the product's intended use as a drug, charge:

"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) and it lacks adequate directions for use. [Misbranded, Section 502(f)(1)]"


OASIS Charge Code – DIRSEXMPT

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


AUSTRALIA


Ceva Animal Health Pty Ltd
Date Published : 09/09/2015
11 Moores Rd , Glenorie, New South Wales AUSTRALIA
68 Y - - 04 Sheep Animal Drugs N.E.C.
Date Published: 09/09/2015

Desc: REGULIN IMPLANT FOR EWES/50 DOSES


BELGIUM


Medichin N.V.
Date Published : 11/29/2016
Grote Baan 97/5 , Hasselt, Limburg BELGIUM
54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 11/29/2016

Desc: Sinking
Notes: Importer: Noah'S Ark; FEI: 3007750328

54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 11/29/2016

Desc: Tendon
Notes: Importer: Noah'S Ark; FEI: 3007750328

54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 11/29/2016

Desc: Hot Feet USA
Notes: Importer: Noah'S Ark; FEI: 3007750328

54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 11/29/2016

Desc: White Tiger
Notes: Importer: Noah'S Ark; FEI: 3007750328

54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 11/29/2016

Desc: Lady Plus Formula
Notes: Importer: Noah'S Ark; FEI: 3007750328

54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 11/29/2016

Desc: Four Yellows
Notes: Importer: Noah'S Ark; FEI: 3007750328

54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 11/29/2016

Desc: Bleeder USA
Notes: Importer: Noah'S Ark; FEI: 3007750328

54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 11/29/2016

Desc: Desert Fire
Notes: Importer: Noah'S Ark; FEI: 3007750328

54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 11/29/2016

Desc: Pro-K
Notes: Importer: Noah'S Ark; FEI: 3007750328

54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 11/29/2016

Desc: Nerve Restore
Notes: Importer: Noah'S Ark; FEI: 3007750328

54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 11/29/2016

Desc: VI Formula
Notes: Importer: Noah'S Ark; FEI: 3007750328

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 11/29/2016

Desc: Tendon
Notes: Importer: Noah'S Ark; FEI: 3007750328

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 11/29/2016

Desc: White Tiger
Notes: Importer: Noah'S Ark; FEI: 3007750328

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 11/29/2016

Desc: Nerve Restore
Notes: Importer: Noah'S Ark; FEI: 3007750328

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 11/29/2016

Desc: Desert Fire
Notes: Importer: Noah'S Ark; FEI: 3007750328

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 11/29/2016

Desc: Bleeder USA
Notes: Importer: Noah'S Ark; FEI: 3007750328

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 11/29/2016

Desc: Four Yellows
Notes: Importer: Noah'S Ark; FEI: 3007750328

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 11/29/2016

Desc: Sinking
Notes: Importer: Noah'S Ark; FEI: 3007750328

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 11/29/2016

Desc: Hot Feet USA
Notes: Importer: Noah'S Ark; FEI: 3007750328

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 11/29/2016

Desc: Lady Plus Formula
Notes: Importer: Noah'S Ark; FEI: 3007750328

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 11/29/2016

Desc: Pro-K
Notes: Importer: Noah'S Ark; FEI: 3007750328

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 11/29/2016

Desc: VI Formula
Notes: Importer: Noah'S Ark; FEI: 3007750328

Reprobiol Sprl
Date Published : 12/10/2014
Lorce 1 , Lorc¿, BELGIUM
68 L - - 99 Disposable/Sigle Use Devices, NEC (Nonhuman)
Date Published: 04/29/2019

Desc: STIMUFOL - Follicle Stimulating Hormone (FSH)

68 M - - 03 Cages, including oxygen cages (Nonhuman)
Date Published: 04/29/2019

Desc: STIMUFOL - Follicle Stimulating Hormone (FSH)

68 M - - 07 Hematology Analyzer (Nonhuman)
Date Published: 04/29/2019

Desc: STIMUFOL - Follicle Stimulating Hormone (FSH)

68 Z - - 99 Animal Medical Devices, NEC
Date Published: 04/29/2019

Desc: STIMUFOL - Follicle Stimulating Hormone (FSH)


CANADA


Adored Beast Apothecary
Date Published : 08/24/2016
129 Gerrish St , Windsor, Nova Scotia CANADA
26 - - - -- Vegetable Oils
Date Published: 08/24/2016

Desc: All Products

54 - - - -- Vit/Min/Prot/Unconv Diet(Human/Animal)
Date Published: 08/24/2016

Desc: All Products

68 - - - -- Animal Devices and Diagnostic Products
Date Published: 08/24/2016

Desc: All Products

Alcon Canada Inc
Date Published : 05/10/2017
2665 Meadowpine Blvd , Mississauga, Ontario CANADA
56 D - - 40 Neomycin (Oligosaccharides)
Date Published: 05/10/2017

Desc: Maxitrol- Neomycin and Polymycin B Sulfates & Dexamethasone Opthalmic Suspension

56 D - - 49 Neomycin, N.E.C. (Oligosaccharides)
Date Published: 05/10/2017

Desc: Maxitrol- Neomycin and Polymycin B Sulfates & Dexamethasone Opthalmic Suspension

56 F - - 30 Polymyxin B Sulfate (Peptides)
Date Published: 05/10/2017

Desc: Maxitrol- Neomycin and Polymycin B Sulfates & Dexamethasone Opthalmic Suspension

64 L - - 19 Dexamethasone (Glucocorticoid)
Date Published: 05/10/2017

Desc: Maxitrol- Neomycin and Polymycin B Sulfates & Dexamethasone Opthalmic Suspension

Groupe Parima Inc.
Date Published : 07/05/2017
4450 Cousens St , Saint-Laurent, Quebec CANADA
61 W - - 18 Miconazole Nitrate (Anti-Fungal) (Not Antibiotic)
Date Published: 07/05/2017

Desc: Malaseb Flush 4 oz.

61 W - - 18 Miconazole Nitrate (Anti-Fungal) (Not Antibiotic)
Date Published: 07/05/2017

Desc: Malaseb Flush 12 oz.

NaturPet Inc.
Date Published : 04/20/2018
300-2130 Leckie Place , Kelowna, British Columbia CANADA
54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 04/20/2018

Desc: NaturPet D Wormer

54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 04/20/2018

Desc: NaturPet Joint Care

54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 04/20/2018

Desc: NaturPet Life Flow

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 04/20/2018

Desc: NaturPet Joint Care

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 04/20/2018

Desc: NaturPet Life Flow

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 04/20/2018

Desc: NaturPet D Wormer

Natures Formulae Health Products Ltd.
Date Published : 04/20/2018
2130 Leckie Pl Suite 300 300 , Kelowna, British Columbia CANADA
54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 04/20/2018

Desc: NaturPet Joint Care

54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 04/20/2018

Desc: NaturPet D Wormer

54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 04/20/2018

Desc: NaturPet Life Flow

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 04/20/2018

Desc: NaturPet D Wormer

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 04/20/2018

Desc: NaturPet Life Flow

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 04/20/2018

Desc: NaturPet Joint Care

The Nutraceutical Medicine Company Inc dba Purica
Date Published : 09/18/2018
6157 Scott Rd , Duncan, British Columbia CANADA
54 Y L - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C., Enrich Anml Fd
Date Published: 09/18/2018

Desc: Recovery EQ for horses

66 V R - 99 Miscellaneous Patent Medicines, Etc., Animal (Non-Food Producing) Rx/Comb Ingredient
Date Published: 09/18/2018

Desc: Recovery EQ for horses


CHINA


Hebei Meiwei Chinese Medicinal Herbs Co., LTD
Date Published : 08/10/2016
No. 188 Henan Road , Anguo, Hebei CHINA
54 - - - -- Vit/Min/Prot/Unconv Diet(Human/Animal)
Date Published: 08/10/2016

Desc: All Products

66 - - - -- Human and Animal Drugs
Date Published: 08/10/2016

Desc: All Products

Shandong Bozhongyuan Biotech Co
Date Published : 08/01/2017
123 Quancheng Rd Jinan , Shandong, CHINA
62 G - - 99 Anti-Inflammatory N.E.C.
Date Published: 04/29/2019

Desc: HYTRYL - (STERILE POST-SURGICAL LAVAGE - STERILE SODIUM HYALURONATE)

64 D - - 99 Emollient, Lubricant, N.E.C.
Date Published: 04/29/2019

Desc: HYTRYL - (STERILE POST-SURGICAL LAVAGE - STERILE SODIUM HYALURONATE)

64 W - - 99 Irrigation Solution N.E.C.
Date Published: 04/29/2019

Desc: HYTRYL - (STERILE POST-SURGICAL LAVAGE - STERILE SODIUM HYALURONATE)

65 F - - 04 Water (Pharm Aid) For Inj, Sterile, U.S.P.
Date Published: 08/01/2017

Desc: HYTRYL - (STERILE POST-SURGICAL LAVAGE - STERILE SODIUM HYALURONATE)

65 F - - 99 Water N.E.C. (Pharmaceutic Aid)
Date Published: 04/29/2019

Desc: HYTRYL - (STERILE POST-SURGICAL LAVAGE - STERILE SODIUM HYALURONATE)

65 R - - 99 Replenisher N.E.C.
Date Published: 04/29/2019

Desc: HYTRYL - (STERILE POST-SURGICAL LAVAGE - STERILE SODIUM HYALURONATE)

66 G - - 99 Surgical/Prosthetic Aid N.E.C.
Date Published: 04/29/2019

Desc: HYTRYL - (STERILE POST-SURGICAL LAVAGE - STERILE SODIUM HYALURONATE)

68 L - - 23 Sterile Flush solution (Nonhuman)
Date Published: 04/29/2019

Desc: HYTRYL - (STERILE POST-SURGICAL LAVAGE - STERILE SODIUM HYALURONATE)

68 N - - 99 Small Hospital Practice Equipment, NEC (Nonhuman)
Date Published: 04/29/2019

Desc: HYTRYL - (STERILE POST-SURGICAL LAVAGE - STERILE SODIUM HYALURONATE)

68 P - - 10 Solutions (Nonhuman)
Date Published: 04/29/2019

Desc: HYTRYL - (STERILE POST-SURGICAL LAVAGE - STERILE SODIUM HYALURONATE)

68 P - - 99 Orthopedic, NEC (Nonhuman)
Date Published: 04/29/2019

Desc: HYTRYL - (STERILE POST-SURGICAL LAVAGE - STERILE SODIUM HYALURONATE)

68 Z - - 99 Animal Medical Devices, NEC
Date Published: 04/29/2019

Desc: HYTRYL - (STERILE POST-SURGICAL LAVAGE - STERILE SODIUM HYALURONATE)

87 M - - OZ Acid, hyaluronic, intraarticular
Date Published: 04/29/2019

Desc: HYTRYL - (STERILE POST-SURGICAL LAVAGE - STERILE SODIUM HYALURONATE)

88 P - - PM General purpose reagent
Date Published: 04/29/2019

Desc: HYTRYL - (STERILE POST-SURGICAL LAVAGE - STERILE SODIUM HYALURONATE)

Shantou Olive Pharmaceutical Co.,Ltd
Date Published : 08/15/2016
NO. 4 Chaoshanlu Xixiang , Jinping , Shantou, Guangdong CHINA
54 - - - -- Vit/Min/Prot/Unconv Diet(Human/Animal)
Date Published: 08/15/2016

Desc: All Products

66 - - - -- Human and Animal Drugs
Date Published: 08/15/2016

Desc: All Products


DENMARK


Vetcur Biotec Aps
Date Published : 04/19/2016
Feldumvej 35 , Haderslev, DENMARK
54 A - - 99 Vitamin, N.E.C.
Date Published: 04/19/2016

Desc: NeVet for cats; organic syrup based supplement
Notes: Product labels and website made medical claims

54 A - - 99 Vitamin, N.E.C.
Date Published: 04/19/2016

Desc: DiVet for cats; organic syrup based supplement
Notes: Product labels and website made medical claims

54 A - - 99 Vitamin, N.E.C.
Date Published: 04/19/2016

Desc: DiVet for horses; nutrition for the digestion
Notes: Product labels and website made medical claims

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 04/19/2016

Desc: DiVet for cats; organic syrup based supplement
Notes: Product labels and website made medical claims

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 04/19/2016

Desc: NeVet for cats; organic syrup based supplement
Notes: Product labels and website made medical claims

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 04/19/2016

Desc: DiVet for horses; nutrition for the digestion
Notes: Product labels and website made medical claims

66 Y - - 99 Exhibits - Other Drug Related Items N.E.C.
Date Published: 05/17/2016

Desc: ViVet Feed supplement for cats and kittens

66 Y - - 99 Exhibits - Other Drug Related Items N.E.C.
Date Published: 05/17/2016

Desc: ImVet Feed supplement for cats and kittens

66 Y - - 99 Exhibits - Other Drug Related Items N.E.C.
Date Published: 05/17/2016

Desc: The Green Oilbased feed supplement for horses

66 Y - - 99 Exhibits - Other Drug Related Items N.E.C.
Date Published: 05/17/2016

Desc: ReVet Feed supplement for cats and kittens

66 Y - - 99 Exhibits - Other Drug Related Items N.E.C.
Date Published: 05/17/2016

Desc: The Red Oilbased feed supplement for horses


FRANCE


Virbac Sa
Date Published : 06/22/2015
1 Main St , Carros, FRANCE
54 F - - 33 Astragalus (Milk Vetch Root), (Herbal & Botanicals, not Teas)
Date Published: 06/22/2015

Desc: PRONEFRA 60ML

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

Desc: PRONEFRA 60ML


IRELAND


CELTIC SEA MINERALS
Date Published : 12/21/2018
Currabinny , Main Street , Cork, Co. CORK IRELAND
54 B - - 01 Calcium (Mineral)
Date Published: 04/25/2019

Desc: Calmin

54 B - - 01 Calcium (Mineral)
Date Published: 12/21/2018

Desc: Equine 74 Gastric

54 B - - 99 Mineral N.E.C.
Date Published: 04/25/2019

Desc: Calmin

70 M - - 02 Horse Mixed Feed Ration
Date Published: 12/21/2018

Desc: Equine 74 Gastric

COPPERFIELD EQUINE THERAPY
Date Published : 02/26/2018
Copperfield Stuf , Kilfrush, IRELAND
54 F - - 03 Angelica (Herbal & Botanicals, not Teas)
Date Published: 02/26/2018

Desc: Copperfield Gold Dietary Supplement

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 02/26/2018

Desc: Copperfield Gold Dietary Supplement

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 02/26/2018

Desc: Copperfield Gold Dietary Supplement

70 M - - 02 Horse Mixed Feed Ration
Date Published: 02/26/2018

Desc: Copperfield Gold Dietary Supplement

70 Y - - 99 Animal Feeds, N.E.C.
Date Published: 02/26/2018

Desc: Copperfield Gold Dietary Supplement


MEXICO


Laboratorios Tornel, S.A.
Date Published : 03/01/2018
Venusiano Carranza No. 24 , Naucalpan, MEXICO
41 - - - -- Dietary Conv Food/Meal Replacements
Date Published: 03/01/2018

Desc: Ca-Aminoplex

41 - - - -- Dietary Conv Food/Meal Replacements
Date Published: 03/01/2018

Desc: Top B15 3

41 - - - -- Dietary Conv Food/Meal Replacements
Date Published: 03/01/2018

Desc: Coccizuril

41 - - - -- Dietary Conv Food/Meal Replacements
Date Published: 03/01/2018

Desc: Enfloxil

41 - - - -- Dietary Conv Food/Meal Replacements
Date Published: 03/01/2018

Desc: Antoplex

41 - - - -- Dietary Conv Food/Meal Replacements
Date Published: 03/01/2018

Desc: K-Ton 12

41 - - - -- Dietary Conv Food/Meal Replacements
Date Published: 03/01/2018

Desc: Super Flumi-Strep

41 - - - -- Dietary Conv Food/Meal Replacements
Date Published: 03/01/2018

Desc: Pangamine

41 - - - -- Dietary Conv Food/Meal Replacements
Date Published: 03/01/2018

Desc: Super Amin-toplex Gallos

54 - - - -- Vit/Min/Prot/Unconv Diet(Human/Animal)
Date Published: 03/01/2018

Desc: Super Flumi-Strep

54 - - - -- Vit/Min/Prot/Unconv Diet(Human/Animal)
Date Published: 03/01/2018

Desc: K-Ton 12

54 - - - -- Vit/Min/Prot/Unconv Diet(Human/Animal)
Date Published: 03/01/2018

Desc: Antoplex

54 - - - -- Vit/Min/Prot/Unconv Diet(Human/Animal)
Date Published: 03/01/2018

Desc: Super Amin-toplex Gallos

54 - - - -- Vit/Min/Prot/Unconv Diet(Human/Animal)
Date Published: 03/01/2018

Desc: Enfloxil

54 - - - -- Vit/Min/Prot/Unconv Diet(Human/Animal)
Date Published: 03/01/2018

Desc: Pangamine

54 - - - -- Vit/Min/Prot/Unconv Diet(Human/Animal)
Date Published: 03/01/2018

Desc: Top B15 3

54 - - - -- Vit/Min/Prot/Unconv Diet(Human/Animal)
Date Published: 03/01/2018

Desc: Coccizuril

54 - - - -- Vit/Min/Prot/Unconv Diet(Human/Animal)
Date Published: 03/01/2018

Desc: Ca-Aminoplex

66 - - - -- Human and Animal Drugs
Date Published: 03/01/2018

Desc: Super Amin-toplex Gallos

66 - - - -- Human and Animal Drugs
Date Published: 03/01/2018

Desc: Antoplex

66 - - - -- Human and Animal Drugs
Date Published: 03/01/2018

Desc: Top B15 3

66 - - - -- Human and Animal Drugs
Date Published: 03/01/2018

Desc: K-Ton 12

66 - - - -- Human and Animal Drugs
Date Published: 03/01/2018

Desc: Pangamine

66 - - - -- Human and Animal Drugs
Date Published: 03/01/2018

Desc: Enfloxil

66 - - - -- Human and Animal Drugs
Date Published: 03/01/2018

Desc: Coccizuril

66 - - - -- Human and Animal Drugs
Date Published: 03/01/2018

Desc: Ca-Aminoplex

66 - - - -- Human and Animal Drugs
Date Published: 03/01/2018

Desc: Super Flumi-Strep

67 - - - -- Type A Medicated Articles
Date Published: 03/01/2018

Desc: Super Amin-toplex Gallos

67 - - - -- Type A Medicated Articles
Date Published: 03/01/2018

Desc: Ca-Aminoplex

67 - - - -- Type A Medicated Articles
Date Published: 03/01/2018

Desc: Enfloxil

67 - - - -- Type A Medicated Articles
Date Published: 03/01/2018

Desc: Super Flumi-Strep

67 - - - -- Type A Medicated Articles
Date Published: 03/01/2018

Desc: Pangamine

67 - - - -- Type A Medicated Articles
Date Published: 03/01/2018

Desc: Antoplex

67 - - - -- Type A Medicated Articles
Date Published: 03/01/2018

Desc: K-Ton 12

67 - - - -- Type A Medicated Articles
Date Published: 03/01/2018

Desc: Coccizuril

67 - - - -- Type A Medicated Articles
Date Published: 03/01/2018

Desc: Top B15 3

68 - - - -- Animal Devices and Diagnostic Products
Date Published: 03/01/2018

Desc: Super Flumi-Strep

68 - - - -- Animal Devices and Diagnostic Products
Date Published: 03/01/2018

Desc: Enfloxil

68 - - - -- Animal Devices and Diagnostic Products
Date Published: 03/01/2018

Desc: Super Amin-toplex Gallos

68 - - - -- Animal Devices and Diagnostic Products
Date Published: 03/01/2018

Desc: Pangamine

68 - - - -- Animal Devices and Diagnostic Products
Date Published: 03/01/2018

Desc: Antoplex

68 - - - -- Animal Devices and Diagnostic Products
Date Published: 03/01/2018

Desc: Coccizuril

68 - - - -- Animal Devices and Diagnostic Products
Date Published: 03/01/2018

Desc: K-Ton 12

68 - - - -- Animal Devices and Diagnostic Products
Date Published: 03/01/2018

Desc: Top B15 3

68 - - - -- Animal Devices and Diagnostic Products
Date Published: 03/01/2018

Desc: Ca-Aminoplex

Lebssa Sa De Cv
Date Published : 06/09/2015
Av De Las Juventudes 13284c Col Rivera , Mexicali B C, MEXICO
54 A - - 01 Vitamin A
Date Published: 06/09/2015

Desc: MEDICAMENTS W/VITAMINS FOR VETERINARY USE ( VITAL E A&D)

54 A - - 14 Vit D
Date Published: 06/09/2015

Desc: MEDICAMENTS W/VITAMINS FOR VETERINARY USE ( VITAL E A&D)

54 A - - 16 Vitamin E (Tocopherol)
Date Published: 06/09/2015

Desc: MEDICAMENTS W/VITAMINS FOR VETERINARY USE ( VITAL E A&D)

54 A - - 90 Multiple Vitamins (MVI-12 vitamin combo) (Vitamin)
Date Published: 06/09/2015

Desc: MEDICAMENTS W/VITAMINS FOR VETERINARY USE ( VITAL E A&D)


NETHERLANDS


Belgica De Weerd
Date Published : 10/17/2016
Van De Reijtstraat 21 , Postbus 4607 , Breda, Noord-brabant NETHERLANDS
54 A - - 01 Vitamin A
Date Published: 10/17/2016

Desc: Belga Coxi

54 A - - 01 Vitamin A
Date Published: 10/17/2016

Desc: Belga White

54 A - - 01 Vitamin A
Date Published: 10/17/2016

Desc: BelgaFox

54 A - - 02 Vitamin B1 (Thiamine)
Date Published: 10/17/2016

Desc: 4 in 1 Mix

54 A - - 02 Vitamin B1 (Thiamine)
Date Published: 10/17/2016

Desc: B.S. Tablets [oral veterinary medicine]

54 A - - 03 Vitamin B2 (Riboflavin)
Date Published: 10/17/2016

Desc: Belgamco

54 A - - 03 Vitamin B2 (Riboflavin)
Date Published: 10/17/2016

Desc: Belga Magix

54 A - - 06 Niacin (Nicotinic Acid) (Vitamin)
Date Published: 10/17/2016

Desc: BelgaBac

54 A - - 13 Vitamin C (Ascorbic Acid)
Date Published: 10/17/2016

Desc: Belga Tai[marketed as Veterinary Medicine]

54 A - - 14 Vit D
Date Published: 10/17/2016

Desc: Parastop [Veterinary medicine]

54 A - - 14 Vit D
Date Published: 10/17/2016

Desc: W.N. Black

54 A - - 14 Vit D
Date Published: 10/17/2016

Desc: BelgaSun

54 A - - 14 Vit D
Date Published: 10/17/2016

Desc: Belgaroni 10% [Veterinary Medicine]

54 A - - 14 Vit D
Date Published: 10/17/2016

Desc: W.N. Red

54 A - - 16 Vitamin E (Tocopherol)
Date Published: 10/17/2016

Desc: Cobel [Veterinary Medicine]

54 A - - 16 Vitamin E (Tocopherol)
Date Published: 10/17/2016

Desc: Essential Oil Belgica

54 A - - 22 Sodium Ascorbate (Vitamin)
Date Published: 10/17/2016

Desc: OrniSpecial Extra [Veterinary Medicine]

54 A - - 22 Sodium Ascorbate (Vitamin)
Date Published: 10/17/2016

Desc: Belga Drops

54 A - - 99 Vitamin, N.E.C.
Date Published: 10/17/2016

Desc: BelgaWormac [marketed as Veterinary Medicine]

54 A - - 99 Vitamin, N.E.C.
Date Published: 10/17/2016

Desc: BelgaBion


NEW ZEALAND


Honey Collection Ltd
Date Published : 06/06/2018
74 Grove Rd , Blenheim, NEW ZEALAND
53 L - - 06 Moisturizing (Skin Care Preparations)
Date Published: 06/06/2018

Desc: Pet Magic UMF Manuka Honey Cream

53 L - - 99 Other Skin Care Preparations, N.E.C.
Date Published: 06/06/2018

Desc: Pet Magic UMF Manuka Honey Cream

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

Desc: Pet Magic UMF Manuka Honey Cream

SOUTH PACIFIC SERA LIMITED
Date Published : 03/18/2019
251 Stafford Street , Timaru, NEW ZEALAND
68 L - - 99 Disposable/Sigle Use Devices, NEC (Nonhuman)
Date Published: 04/29/2019

Desc: Ovagen - Follicle Stimulating Hormone (FSH)

68 M - - 03 Cages, including oxygen cages (Nonhuman)
Date Published: 04/29/2019

Desc: Ovagen - Follicle Stimulating Hormone (FSH)

68 M - - 07 Hematology Analyzer (Nonhuman)
Date Published: 04/29/2019

Desc: Ovagen - Follicle Stimulating Hormone (FSH)

68 Z - - 99 Animal Medical Devices, NEC
Date Published: 04/29/2019

Desc: Ovagen - Follicle Stimulating Hormone (FSH)

South Pacific Sera Limited
Date Published : 12/10/2014
26 Kennels Road , R D 4 , Timaru, NEW ZEALAND
68 L - - 99 Disposable/Sigle Use Devices, NEC (Nonhuman)
Date Published: 04/29/2019

Desc: Ovagen - Follicle Stimulating Hormone (FSH)

68 M - - 03 Cages, including oxygen cages (Nonhuman)
Date Published: 04/29/2019

Desc: Ovagen - Follicle Stimulating Hormone (FSH)

68 M - - 07 Hematology Analyzer (Nonhuman)
Date Published: 04/29/2019

Desc: Ovagen - Follicle Stimulating Hormone (FSH)

68 Z - - 99 Animal Medical Devices, NEC
Date Published: 04/29/2019

Desc: Ovagen - Follicle Stimulating Hormone (FSH)


PHILIPPINES


Premium Lab
Date Published : 12/05/2016
498 M.H. Del Pilar St. , Rizal, PHILIPPINES
60 W - - 26 Piperazine (Anthelmintic)
Date Published: 12/05/2016

Desc: Wormal Tablets

60 W - - 99 Anthelmintic, N.E.C.
Date Published: 12/05/2016

Desc: Wormal Tablets

68 A - - 99 Other Animal, N.E.C. Anthelmintic
Date Published: 12/05/2016

Desc: Wormal Tablets


SOUTH AFRICA


Afriplex ( Pty ) Ltd.
Date Published : 10/19/2016
10 De Vreugde Crescent , Paarl, Western Cape SOUTH AFRICA
41 B - - 99 Foods with Supplemental Nutrients Added, with or without Artifical Sweetners
Date Published: 10/19/2016

Desc: Regal Joint Health Remedy

41 B - - 99 Foods with Supplemental Nutrients Added, with or without Artifical Sweetners
Date Published: 10/19/2016

Desc: Regal Skin Care Remedy

41 B - - 99 Foods with Supplemental Nutrients Added, with or without Artifical Sweetners
Date Published: 10/19/2016

Desc: Regal Skin Care Combo

41 B - - 99 Foods with Supplemental Nutrients Added, with or without Artifical Sweetners
Date Published: 10/19/2016

Desc: Regal Glossy Coat Remedy

53 E - - 06 Shampoos (Hair Preparations, Non-coloring)
Date Published: 10/19/2016

Desc: Tick & Flea Shampoo

61 X - - 99 Anti-Histaminic N.E.C.
Date Published: 10/19/2016

Desc: Regal Skin Care Combo

61 X - - 99 Anti-Histaminic N.E.C.
Date Published: 10/19/2016

Desc: Regal Skin Care Remedy

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 10/19/2016

Desc: Regal Glossy Coat Remedy

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 10/19/2016

Desc: Regal Joint Health Remedy

68 H - - 20 Parasiticides (External) Used More Than 1 Species
Date Published: 10/19/2016

Desc: Tick & Flea Shampoo

HERBEX PTY LIMITED
Date Published : 10/19/2016
Unit 2 , Nexus Place , Cape Town, Western Cape SOUTH AFRICA
41 B - - 99 Foods with Supplemental Nutrients Added, with or without Artifical Sweetners
Date Published: 10/19/2016

Desc: Regal Joint Health Remedy

41 B - - 99 Foods with Supplemental Nutrients Added, with or without Artifical Sweetners
Date Published: 10/19/2016

Desc: Regal Glossy Coat Remedy

41 B - - 99 Foods with Supplemental Nutrients Added, with or without Artifical Sweetners
Date Published: 10/19/2016

Desc: Regal Skin Care Combo

41 B - - 99 Foods with Supplemental Nutrients Added, with or without Artifical Sweetners
Date Published: 10/19/2016

Desc: Regal Skin Care Remedy

53 E - - 06 Shampoos (Hair Preparations, Non-coloring)
Date Published: 10/19/2016

Desc: Tick & Flea Shampoo

61 X - - 99 Anti-Histaminic N.E.C.
Date Published: 10/19/2016

Desc: Regal Skin Care Combo

61 X - - 99 Anti-Histaminic N.E.C.
Date Published: 10/19/2016

Desc: Regal Skin Care Remedy

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 10/19/2016

Desc: Regal Joint Health Remedy

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 10/19/2016

Desc: Regal Glossy Coat Remedy

68 H - - 20 Parasiticides (External) Used More Than 1 Species
Date Published: 10/19/2016

Desc: Tick & Flea Shampoo


SPAIN


Laboratorios Calier S.A.
Date Published : 12/10/2014
Calle Barcelones , Les Franqueses Del Valles, Barcelona SPAIN
64 M - - 99 Gonad-Stimulating Principle N.E.C.
Date Published: 06/06/2017

Desc: Pluset - Follicle Stimulating Hormone (FSH)

68 L - - 99 Disposable/Sigle Use Devices, NEC (Nonhuman)
Date Published: 04/29/2019

Desc: Pluset - Follicle Stimulating Hormone (FSH)

68 M - - 03 Cages, including oxygen cages (Nonhuman)
Date Published: 04/29/2019

Desc: Pluset - Follicle Stimulating Hormone (FSH)

68 M - - 07 Hematology Analyzer (Nonhuman)
Date Published: 04/29/2019

Desc: Pluset - Follicle Stimulating Hormone (FSH)

68 Z - - 99 Animal Medical Devices, NEC
Date Published: 04/29/2019

Desc: Pluset - Follicle Stimulating Hormone (FSH)


SWEDEN


Enzymatica Ab
Date Published : 03/13/2015
Ideon Science Park , Lund, SWEDEN
61 W - - -- A-Fungal
Date Published: 03/13/2015

Desc: Kalvatin Dermal Gel

62 F - - -- A-Infective, Topical
Date Published: 03/13/2015

Desc: Kalvatin Dermal Gel

62 G - - -- A-Inflammatory
Date Published: 03/13/2015

Desc: Kalvatin Dental Gel

62 G - - -- A-Inflammatory
Date Published: 03/13/2015

Desc: Kalvatin Dermal Gel

62 G - - -- A-Inflammatory
Date Published: 03/13/2015

Desc: Kalvatin Dental Spray

62 S - - -- A-Seborrheic
Date Published: 03/13/2015

Desc: Kalvatin Dermal Gel

63 R - - -- Dental Caries Prophyl
Date Published: 03/13/2015

Desc: Kalvatin Dental Spray

63 R - - -- Dental Caries Prophyl
Date Published: 03/13/2015

Desc: Kalvatin Dental Gel

63 S - - -- Dental Protect
Date Published: 03/13/2015

Desc: Kalvatin Dental Spray

63 S - - -- Dental Protect
Date Published: 03/13/2015

Desc: Kalvatin Dental Gel

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 03/13/2015

Desc: Kalvatin Dental Spray

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 03/13/2015

Desc: Kalvatin Dermal Gel

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 03/13/2015

Desc: Kalvatin Dental Gel

68 B - - -- Anti-Infective
Date Published: 03/13/2015

Desc: Kalvatin Dental Gel

68 C - - -- Antiseptic
Date Published: 03/13/2015

Desc: Kalvatin Dental Gel

68 K - - -- Wound Dressing
Date Published: 03/13/2015

Desc: Kalvatin Dental Gel

68 Y - - -- Animal Drugs N.E.C.
Date Published: 03/13/2015

Desc: Kalvatin Dental Spray

68 Y - - -- Animal Drugs N.E.C.
Date Published: 03/13/2015

Desc: Kalvatin Dental Gel


UNITED KINGDOM


Optimised Energetics Ltd
Date Published : 03/07/2016
Unit 4 , Castle Keep; High Street , Wadhurst, East Sussex UNITED KINGDOM
56 G - - 99 Antifungal N.E.C.
Date Published: 03/07/2016

Desc: Colloidal Silver Topical Animal Drug Products

61 H - - 99 Anti-Bacterial, N.E.C.
Date Published: 03/07/2016

Desc: Colloidal Silver Topical Animal Drug Products

62 H - - 99 Anti-Microbial N.E.C.
Date Published: 03/07/2016

Desc: Colloidal Silver Topical Animal Drug Products

Superfix Supplements Ltd
Date Published : 06/02/2017
Rallt Deg The Gatewaywirral , Caernarfoncaernarfon, UNITED KINGDOM
54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 06/02/2017

Desc: Superfix Performance - Equine Nutriceutical

66 Y - - 99 Exhibits - Other Drug Related Items N.E.C.
Date Published: 06/02/2017

Desc: Superfix Performance - Equine Nutriceutical

70 Y - - 99 Animal Feeds, N.E.C.
Date Published: 06/02/2017

Desc: Superfix Performance - Equine Nutriceutical


UNITED STATES


Dr. Xie's Jing Tang Herbal
Date Published : 08/10/2016
9700 W Highway 318 , Reddick, FL 32686-2219 UNITED STATES
54 - - - -- Vit/Min/Prot/Unconv Diet(Human/Animal)
Date Published: 08/10/2016

Desc: All Products

66 - - - -- Human and Animal Drugs
Date Published: 08/10/2016

Desc: All Products

Noah'S Ark
Date Published : 11/29/2016
9552 Seiobt , Versailles, OH 45380 UNITED STATES
54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 11/29/2016

Desc: Hot Feet USA
Notes: FOREIGN MANUFACTURER: Medichin N.V.; FEI: 3005277669

54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 11/29/2016

Desc: Four Yellows
Notes: FOREIGN MANUFACTURER: Medichin N.V.; FEI: 3005277669

54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 11/29/2016

Desc: Sinking
Notes: FOREIGN MANUFACTURER: Medichin N.V.; FEI: 3005277669

54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 11/29/2016

Desc: Tendon
Notes: FOREIGN MANUFACTURER: Medichin N.V.; FEI: 3005277669

54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 11/29/2016

Desc: Nerve Restore
Notes: FOREIGN MANUFACTURER: Medichin N.V.; FEI: 3005277669

54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 11/29/2016

Desc: Bleeder USA
Notes: FOREIGN MANUFACTURER: Medichin N.V.; FEI: 3005277669

54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 11/29/2016

Desc: VI Formula
Notes: FOREIGN MANUFACTURER: Medichin N.V.; FEI: 3005277669

54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 11/29/2016

Desc: Pro-K
Notes: FOREIGN MANUFACTURER: Medichin N.V.; FEI: 3005277669

54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 11/29/2016

Desc: Lady Plus Formula
Notes: FOREIGN MANUFACTURER: Medichin N.V.; FEI: 3005277669

54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 11/29/2016

Desc: Desert Fire
Notes: FOREIGN MANUFACTURER: Medichin N.V.; FEI: 3005277669

54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 11/29/2016

Desc: White Tiger
Notes: FOREIGN MANUFACTURER: Medichin N.V.; FEI: 3005277669

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 11/29/2016

Desc: Tendon
Notes: FOREIGN MANUFACTURER: Medichin N.V.; FEI: 3005277669

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 11/29/2016

Desc: Four Yellows
Notes: FOREIGN MANUFACTURER: Medichin N.V.; FEI: 3005277669

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 11/29/2016

Desc: Bleeder USA
Notes: FOREIGN MANUFACTURER: Medichin N.V.; FEI: 3005277669

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 11/29/2016

Desc: Nerve Restore
Notes: FOREIGN MANUFACTURER: Medichin N.V.; FEI: 3005277669

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 11/29/2016

Desc: Hot Feet USA
Notes: FOREIGN MANUFACTURER: Medichin N.V.; FEI: 3005277669

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 11/29/2016

Desc: White Tiger
Notes: FOREIGN MANUFACTURER: Medichin N.V.; FEI: 3005277669

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 11/29/2016

Desc: Desert Fire
Notes: FOREIGN MANUFACTURER: Medichin N.V.; FEI: 3005277669

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 11/29/2016

Desc: VI Formula
Notes: FOREIGN MANUFACTURER: Medichin N.V.; FEI: 3005277669

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 11/29/2016

Desc: Lady Plus Formula
Notes: FOREIGN MANUFACTURER: Medichin N.V.; FEI: 3005277669

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 11/29/2016

Desc: Sinking
Notes: FOREIGN MANUFACTURER: Medichin N.V.; FEI: 3005277669

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 11/29/2016

Desc: Pro-K
Notes: FOREIGN MANUFACTURER: Medichin N.V.; FEI: 3005277669