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U.S. Department of Health and Human Services

Enforcement Report - Week of April 30, 2014

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Product Type Product Description Code Info Classification Reason for Recall Recalling Firm
Devices The CEP 8 SpectrumGreen (SG) ASR Probe Kit, 20ul (list 06J37-018) is an Analyte Specific Reagent (ASR) containing a single vial of CEP 8 spectrum green probe and a Certificate of Analysis (COA). Chromosome enumeration probes (CEP) are chromosome-specific FISH probes that hybridize to highly repetitive human satellite DNA sequences, usually located near centromeres. CEP signals enable the identification and enumeration of human chromosomes in interphase and metaphase cells from fresh and archived samples. The label for CEP 8 SG ASR Probe Kit indicates it is an Analyte Specific Reagent, and analytical and performance characteristics are not established. List Number: 06J37-018; Lot Number: 440023 Class III 20 kits of CEP 8 SG ASR Probe (list 06J37-018, lot 440023), contained Vysis CEP 4 (Alpha Satellite) SG Probe, 20u, (part 32-112004 lot 438814), instead of the expected CEP 8 probe. Abbott Molecular
Drugs JaDera, 100% Natural Weight Loss Supplement, capsules, 30 count bottle Manufacturing Codes: 10.06.2011 Exp. 09.06.2013 Class I Marketed without an Approved NDA/ANDA: Products found to contain undeclared sibutramine. Sibutramine was removed from the U.S. market for safety reasons, making these products unapproved new drugs. Dolphin Intertrade Corporation
Drugs XIYOUJI QINGZHI CAPSULE, 300mg, 20 count box All Lots Class I Marketed without an Approved NDA/ANDA: Products found to contain undeclared sibutramine. Sibutramine was removed from the U.S. market for safety reasons, making these products unapproved new drugs. Dolphin Intertrade Corporation
Drugs RezzRX capsules, Single Blister Pack and 20 count bottle, Distributed By: Fossil Fuel Products, LLC Atlanta, GA 30309 Lots QL110408B046, QL110714A102 Exp. 11/13 Class I Marketed Without an Approved NDA/ANDA: Fossil Fuel Products, is recalling RezzRX due to undeclared hydroxylthiohomosildenafil and aminotadalafil. Fossil Fuel Products, LLC
Drugs Glycopyrrolate (MDV) 0.2 MG/ML Injectable, 5 mL Vials, Sterile Serum Vials/Sterile Syringes, for use by a licensed professional only, not for resale, MD Custom Rx, 19035 W Capitol Dr Ste 105, Brookfield, WI 53045. Lot #: 10292013@15, Beyond Use Date: 11/28/2013 Class I Non-Sterility: One lot of Glycopyrrolate solution for injection was found to be contaminated with Bacillus thuringiensis. Brookfield Prescription Center Inc
Cosmetics Obagi Medical C-Cleansing Gel, deeply Cleans to Remove Makeup and Excess Oil, 33.8 fl. oz. (1 L), Not for Retail Sale, Distributed by OMP, Inc., Long Breach, CA 90806 Lot No. 1304400-13B1017, UPC Code 362032070544 Class III Product was mislabeled as Obagi Medical Toner Valeant Pharmaceuticals North America LLC DBA Orapharma Inc.
Devices Heartware HVAD Pump Implant Kit (Heartware Ventricular Assist Device) Product Usage: For use as a bridge-to-cardiac transplantation in patients who are at risk of death from refractory end-stage left ventricular heart failure. The HeartWare VAS is designed for in-hospital and out-of-hospital settings, including transportation via fix-wing aircraft or helicopter. Catalog Numbers: 1100, 1101, 1102, 1103, 1104, and 1205. Serial Numbers: HW001 to HW 11215 and HW20001 to HW 20296. Class I The housing to the Pump's driveline connector became partially or fully separated from the front portion of the driveline connector. HeartWare Inc
Devices VITROS Chemistry Products CDM PROM (Calibration Data Module) No. 0168, Catalog Number/REF 199 9077, used in conjunction with: VITROS Chemistry Products CRSC DT Slides, Generation (GEN) 82, REF 6802721, and VITROS DT Calibrator Kit, Product Code 1957924, and tested on the VITROS DT60/DT60 II Chemistry System; IVD --- Made in USA by Ortho-Clinical Diagnostics, Inc. Rochester, NY Calibration Data Module Rev. 0168, REF 199 9077 used in conjuction with of VITROS Chemistry Products CRSC DT Slides, Generation (GEN) 82, Product Code 6802721. Class II Customers were unable to calibrate, or use previously calibrated, VITROS DT CRSC slides (REF/Product Code 6802721), GEN 82, on the VITROS DT II System, when using Calibration Data Module (CDM) Rev. 168 (REF/Product Code 199 9077), as CDM 168 does not contain calibration parameters for DT CRSC. Ortho-Clinical Diagnostics
Devices RaySearch Ray Station Radiation Therapy Treatment Planning System, Stand-alone software. Versions 2.0, 2.5, 3.0, 3.5 and 4.0. Versions: 2.0.0.15, 2.5.1.89, 3.0.0.251, 3.5.0.16, 3.5.1.6, 4.0.0.14, 4.0.1.4, 4.0.2.9. Class II RaySearch Laboratories has recalled "RaySearch Ray Station 2.0, 2.5, 3.0, 3.5 and 4.0" software due to dose miscalculations for bolus/external/fixation support structures on CT-image. RAYSEARCH LABORATORIES AB
Devices MULTIX FUSION. The Multix Fusion system is a radiographic system used in hospitals, clinics, and medical practices. Multix Fusion enables radiographic exposures of the whole body including: skull, chest, abdomen, and extremities and may be used on pediatric, adult and bariatric patients. model nos. 10746665, 10746666, 10847610, 10746700 Class II It was observed that the corrugated hose holder above the 3D rail on the Multix Fusion system became loose, and could potentially crash down during an examination. Siemens Medical Solutions USA, Inc
Drugs Non-Drowsy 24 Hour Formula Allergy Relief and Nasal Decongestant, Pseudoephedrine Sulfate, USP 240 mg , Loratadine, USP, 10 mg, 5, 10, 15 count blister packs, OTC Only. Labeled A) CVS Allergy Relief - D, Pseudoephedrine, USP 240 mg/Nasal Decongestant Loratadine, USP 10 mg/Antihistamine Extended Release Tablets, 5-count box Distributed by CVS Pharmacy Inc., One CVS Drive, Woonsocket, RI 02805 UPC 050428049631 B) Discount Drug Mart Non-Drowsy 24 Hour Formula Allergy Relief and Nasal Decongestant, Loratadine, USP 10 mg/Antihistamine Pseudephrine Sulfate, USP 240 mg/Nasal Decongestant Extended Release Tablets, 15-count box Distributed by Drug Mart-Food Fair Medina, Ohio 44256 UPC 093351116285 C) Kroger Non-Drowsy Allergy and Congestion Loratadine and Pseudoephedrine Extended Release Tablets Pseudoephedrine Sulfate, USP 240 mg Nasal Decongestant Loratadine, USP 10 mg, Antihistamine 10- count box, Distributed by The Kroger Co., Cincinnati, Ohio 45202 NDC 30142-0724-69. D) Sunmark Allergy & Congestion Lorata*dine D Pseudoephedrine Sulfate, USP 240 mg/Nasal Decongestant Loratadine, USP 10 mg/Antihistamine Extended Release Tablets, Indoor & Outdoor Allergies, Non-Drowsy 10- count box, Distributed by Mckesson One Post Street, San Francisco, CA 94104 NDC 49348-543-01 E) Good Neighbor Pharmacy Non-Drowsy Allergy and Congestion Relief pseudoephedrine sulfate, USP 240 mg/nasal decongestant loratadine, USP 10 mg/antihistamine Indoor & Outdoor Allergies Extended-Release Tablets, 10- count box, Distributed by Amerisource Bergen 1300 Morris Drive, Chesterbrook, PA 19087 NDC46122-0167-52 F) H-E-B Allergy Relief - D Non-Drowsy- 24 Hour Formula Loratadine, USP 10mg/Antihistamine Pseudoephedrine Sulfate, USP 240 mg/Nasal Decogestant Indoor & Outdoor Allegies, Allergy & Congestion Extended-Release Tablets 10-count box, Distributed by H-E-B San Antonio, TX 78204 NDC 37808-0724-69 G) Rite Aid Pharmacy allergy relief & nasal decongestant loratadine USP, 10 mg, pseudoephedribe sulfate USP, 240 mg, antihistamine & nasal degestant, extended release tablets, 10- count box, Distributed by: Rite Aid 30 Hunter Lane Camp Hill, PA 17011 UPC 0118223315555 Lot # 2554936, 2554938; Exp 09/15 Class II Defective Container: An unacceptable level of blister defects have been identified in Loratadine and Pseudoephedrine Sulfate Extended Release Tablets, 10 mg/240 mg. Ohm Laboratories, Inc.
Devices Sengstaken Tube and Sengstaken-Blakemore Tube. Teleflex product codes 204800, 204802, and 204803, a gastrointestinal tube and accessories, consisting of flexible or semi-rigid tubing used for instilling fluids into, withdrawing fluids from, splinting, or suppressing bleeding of the alimentary tract. Lots 10251, 10201, 10301, 10401, 10481, 10381, 11041, 11321, 12151, 12231, 1226, 11201, 12311, 123821, 12474, 13151, 13191, 13211, 13261, 13381 Class II Sterility of the product cannot be guaranteed. Teleflex Medical
Biologics Platelets Pheresis Leukocytes Reduced W050912000317 Class II Blood product, collected from a donor for whom donor suitability was not adequately determined, was distributed. HCSC-Blood Center
Devices Proteus 235 Proton Therapy System Legacy Software version 7.2.7 and higher, models 110, 112, 113, and 116. Proton therapy Proteus 235 Proton Therapy System Legacy Software version 7.2.7 and higher, models 110, 112, 113, and 116. Class II Internal testing of the Proteus 235 Proton Therapy System revealed incorrect dose rate calculation in case of beam line option other than Zero (0). Ion Beam Applications S.A.
Drugs VPRIV® (velaglucerase alfa for injection) , Lyophilized Powder, 400 Units/vial, Rx Only. Shire Human Genetic Therapies, Inc. 300 Shire Way, Lexington, MA 02421. NDC: 54092-701-04. US: Lot #: FEW13-001, FEW13-002, FED13-006; Expiry: 10/15. Mexico: Lot #: FED 013-010; Expiry: 10/15. Columbia: Lot #: FED 013-011; Expiry: 10/15. Class I Presence of Particulate Matter; Particulates identified as stainless steel and barium sulfate. Shire Human Genetic Therapies, Inc.
Biologics Red Blood Cells Leukocytes Reduced W227712350683 Class II Blood products, collected from a donor who was at risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed. Mid-South Regional Blood Center
Biologics Blood and Blood Products for Reprocessing W227712350683 Class II Blood products, collected from a donor who was at risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed. Mid-South Regional Blood Center
Biologics Blood and Blood Products for Reprocessing W036513108377 Class II Blood product, collected from a donor who was at risk for variant Creutzfeldt-Jakob Disease (vCJD), was distributed. LifeShare Blood Centers
Devices LifeShield LATEX-FREE HemoSet 100 mL Burette I.V. PlumSet, Nonvented, 105 inch with Prepierced Reseals, OPTION-LOK and Inline Dual Channel Cassette. For administration of blood and blood bags for use with Plum Series Infusers. Product List Number: 112410403; Lot Numbers: 280055H, 341005H Class II Hospira identified an incorrect lower lid (set component) had been supplied and was being used during the manufacturing process of list number 11241-03, a HemoSet containing a burette and blood filter, intended for infusion of blood/blood products. In a gravity delivery, the correct lower lid dispenses 15 drops per mL and the incorrect lower lid found dispenses 10 drops per mL. Hospira Inc.
Biologics Red Blood Cells (Apheresis) Leukocytes Reduced W036513147804 Class III Blood product, which did not meet the minimum requirement for Red Blood Cell recovery, was distributed. LifeShare Blood Centers
Biologics Platelets Pheresis Leukocytes Reduced Irradiated W2885103008452, W288314000067, W287914000029 Class II Blood products, which were incorrectly stored in a single storage bag, were distributed. LifeSource
Biologics Platelets Pheresis Leukocytes Reduced W287313002231, W288314000014 Class II Blood products, which were incorrectly stored in a single storage bag, were distributed. LifeSource
Biologics Red Blood Cells Leukocytes Reduced W280313301085 Class II Blood products, which were collected from a donor who traveled to a malarial endemic area, were distributed. Upstate New York Transplant Services
Biologics Red Blood Cells Leukocytes Reduced W035213060977E Class II Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed. Carter BloodCare
Biologics Platelets W035213060977E Class II Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed. Carter BloodCare
Biologics Blood and Blood Products for Reprocessing W035213060977E Class III Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed. Carter BloodCare
Biologics Red Blood Cells Leukocytes Reduced W036213874696 Class II Blood product, which was not quarantined subsequent to receiving information regarding a post donation illness, was distributed. Belle Bonfils Memorial Blood Center
Devices Stryker PenAdapt"; Rx Only, Sterile. This device is an accessory to an electrosurgical unit (ESU). The PenAdapt is used to remove smoke, particles, and body and casual fluids from the point of surgical activity during surgical procedures that use ESU for cutting and cauterizing. Part Number 0702-045-027 Class II During packaging verification testing, a failure occurred due to cuts in the packaging potentially causing a breach in the sterile barrier. Additional testing identified microscopic aluminum metal shavings and foreign particles estimated in size to be between 0.01inches x 0.015 inches to 0.03 inches x 0.04 inches that were introduced during the manufacturing process and were sterilized within the package of the product. Stryker Instruments Div. of Stryker Corporation
Biologics Plasma Frozen within 24 hours (FP24) W087613610841 Class II Blood products, collected from a donor who was taking the medication Propecia, were distributed. Virginia Blood Services
Biologics Red Blood Cells Leukocytes Reduced W087613610841 Class II Blood products, collected from a donor who was taking the medication Propecia, were distributed. Virginia Blood Services
Biologics Red Blood Cells Leukocytes Reduced W067113096468 Class III Blood product, labeled with the incorrect anticoagulant, was distributed. Blood Center Hammond Laboratory (the)
Biologics Red Blood Cells Leukocytes Reduced W201914018033 Class III Blood Product, prepared from an overweight unit, was distributed. American Red Cross Blood Services Tennessee Valley Region
Biologics Source Plasma AY0882006 Class III Source Plasma, collected from an ineligible donor, was distributed. Yale Blood Plasma LLC
Biologics Source Plasma TT0296070 Class II Blood product, collected from a donor in which donor suitability was not adequately determined, was distributed. DCI Biologicals Temple Terrace, LLC
Biologics Plasma Frozen W041613052132U; Class II Blood product, manufactured from an overweight whole blood unit, was distributed. Blood Systems, Inc. DBA United Blood Services
Biologics Red Blood Cells Leukocytes Reduced W115913223046; Class II Blood product, which was collected from a donor who traveled to a malarial endemic area, was distributed. Central California Blood Center
Biologics Platelets Pheresis Leukocytes Reduced W201713805168 Class II Blood product, in which quality control/distribution of product did not meet specifications. American National Red Cross (The) - North Central Region
Devices Oxoid Legionella Latex Test, DR0800M, containing 50 tests per box. The box contains a variety of components, one of which is Oxoid L. pneumophila Group 2-14 Latex Reagent, DR0802. The responsible firm on the label is Oxoid Ltd., Basingstoke, Hants, England. DR0800M box lot numbers 1314413, Exp. 30Jun2014, and 1301907, Exp. 31May2014; DR0802 reagent bottle lot number 1265366, exp. June 2014 Class II A reagent contained within the product may return false negative results. Remel Inc
Devices Oxoid Legionella Pneumo Groups 2-14, DR0802M, containing 50 tests per box. The box contains a variety of components, one of which is Oxoid L. pneumophila Group 2-14 Latex Reagent, DR0802. The responsible firm on the label is Oxoid Ltd., Basingstoke, Hants, England. DR0802M box lot number 1265362, Exp. 30Jun2014; DR0802 reagent bottle lot number 1265366, exp. June, 2014 Class II A reagent contained within the product may return false negative results. Remel Inc
Devices TRABECULAR METAL MODULAR ACETABULAR SYSTEM, Shell with Cluster Holes, Porous 60mm. Catalog number 00-6202-060-22; Hip implant component. 00-6202-060-22; lot 62490588 Class II Three complaints were received in which it was noted intra-operatively that the shell was missing the locking ring. Zimmer, Inc.
Drugs Nicotine polacrilex lozenge, 2 mg, Cherry Flavor, 72 count vials, 81 count vials, and 108 count vials. OTC. Labeled a. Nicorette, Distributed By: GlaxoSmithKline Consumer Healthcare, L.P., Moon Township, PA 15108. Made in Switzerland. 72 Count NDC: 0135-0512-01, 81 Count NDC: 0135-0512-02, 108 Count NDC: 0135-0512-03 b. Nicotine Lozenge Kroger, Distributed by: The Kroger Company, Cincinnati, Ohio 45202, 72 Count NDC:30142-663-01, and c. Nicotine Walgreens, Distributed by: Walgreen Co., 200 Wilmot Rd., Deerfield, IL 60015. 72 Count NDC: 0363-0446-01. Labeled A) 72 Ct Vial: Lot #13468 (exp 4/14), 13618 (exp 6/14) & 14105 (exp 2/15); 81 Ct- Vial, Lot #13815 (exp 10/14), 13864 (exp 11/14) & 13941 (exp 12/14); 108 Ct- Vial, Lot # 13574 (exp 7/14). Labeled B) 72 Ct Vial, Lot #13573 (exp 6/14) & 14257 (exp  ...
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Class III Failed Lozenge Specifications; Lozenges are overly thick, overly soft, and sub and superpotent. GlaxoSmithKline Consumer Healthcare; dba-GlaxoSmithKline
Drugs Nicotine polacrilex lozenge, 4 mg, Cherry Flavor, 72 count cartons, 81 count cartons, and 108 count cartons. OTC. Labeled a. Nicorette, Distributed By: GlaxoSmithKline Consumer Healthcare, L.P., Moon Township, PA 15108. Made in Switzerland. 72 Count NDC: 0135-0513-01, 81 Count NDC: 0135-0513-02, 108 Count NDC: 0135-0513-03 b. Nicotine Lozenge Kroger, Distributed by: The Kroger Company, Cincinnati, Ohio 45202, 72 Count NDC:30142-664-01, and c. Nicotine Walgreens, Distributed by: Walgreen Co., 200 Wilmot Rd., Deerfield, IL 60015. 72 Count NDC: 0363-9200-01. Labeled A) 72 Ct Vial, Lot # 13481 (exp 5/14), 13674  ...
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Class III Failed Lozenge Specifications; Lozenges are overly thick, overly soft, and sub and superpotent. GlaxoSmithKline Consumer Healthcare; dba-GlaxoSmithKline
Drugs Nicotine polacrilex lozenge, 4 mg, Original Flavor, 72 count cartons, 81 count cartons, and 108 count cartons. OTC. Labeled a. Nicorette, Distributed By: GlaxoSmithKline Consumer Healthcare, L.P., Moon Township, PA 15108. Made in Switzerland. 72 Count NDC: 0135-0511-01,108 Count NDC: 0135-0515-03, b. Nicotine Lozenge Kroger, Lozenge Kroger, Distributed by: The Kroger Company, Cincinnati, Ohio 45202, 72 Count NDC:30142-862-01 and c. Nicotine Walgreens, Distributed by: Walgreen Co., 200 Wilmot Rd., Deerfield, IL 60015. 72 Count NDC: 0363-0209-01, 108 Count NDC: 0363-0209-07. Labeled A) 72 Ct Vial: Lot # 13434 (exp 4/14), 13546 (exp 5/14), 13907 (exp 11/14), 14020 (exp 1/15), 14107 (exp 3/15), 14183 (exp 4/15), 14273 (exp 7/15), 14335 (exp 8/15), & 14421 (exp 9/15), 12F27N (exp 4/14), 12K01N (exp 5/14), 13A25N (exp 11/14) & 13C18N (exp 1/15); 108 Ct  ...
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Class III Failed Lozenge Specifications; Lozenges are overly thick, overly soft, and sub and superpotent. GlaxoSmithKline Consumer Healthcare; dba-GlaxoSmithKline
Drugs Nicotine polacrilex lozenge, 2 mg, Original Flavor, 72 count cartons, 81 count cartons, and 108 count cartons. OTC. Labeled a. Nicorette, Distributed By: GlaxoSmithKline Consumer Healthcare, L.P., Moon Township, PA 15108. Made in Switzerland. 72 Count NDC: 0135-0510-01,108 Count NDC: 0135-0514-03, b. Nicotine Lozenge Kroger, Lozenge Kroger, Distributed by: The Kroger Company, Cincinnati, Ohio 45202, 72 Count NDC: 30142-861-01. c. Nicotine Walgreens, Distributed by: Walgreen Co., 200 Wilmot Rd., Deerfield, IL 60015. 108 Count NDC: 0363-0208-07. Labeled A) 72 Count Vial, Lot # 13404 (exp 4/14),13499 (exp 5/14), 13549 (exp 6/14), 14004 (exp 1/15), 14079 (exp 2/15), 14178 (exp 5/15), 14297 (exp 7/15) & 14425 (exp 9/15); 108 Ct Vial: Lot # 13449 (exp 5/14), 13657 (exp 8/14), 13723 (exp 8/14), 13781 (exp  ...
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Class III Failed Lozenge Specifications; Lozenges are overly thick, overly soft, and sub and superpotent. GlaxoSmithKline Consumer Healthcare; dba-GlaxoSmithKline
Drugs Nicotine polacrilex lozenge, 2 mg, Mint Flavor, 81 count cartons and 189 count cartons. OTC. Labeled Nicorette, Distributed By: GlaxoSmithKline Consumer Healthcare, L.P., Moon Township, PA 15108. Made in Switzerland. 81 Count NDC: 0135-0510-05, 189 Count NDC: 0135-0510-03. 81 Ct Vial, Lot # 13727 (exp 8/14), 13816 (exp 10/14), & 13965 (exp 12/14); 189 Ct Vial, Lot # 12H17N (exp 4/14), 12H20N (exp 6/14), 12J16N (exp 6/14), 12K03N (exp 9/14), 12L05N (exp 10/14), 12L07N (exp 9/14), 12L17N (exp 10/14), 13A04N (exp 11/14), 13A23N (exp 11/14), 13C04N (exp 1/15),  ...
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Class III Failed Lozenge Specifications; Lozenges are overly thick, overly soft, and sub and superpotent. GlaxoSmithKline Consumer Healthcare; dba-GlaxoSmithKline
Drugs Nicotine polacrilex lozenge, 4 mg, Mint Flavor, 81 Lozenge and 189 Lozenge Vials. OTC. Labeled Nicorette, Distributed By: GlaxoSmithKline Consumer Healthcare, L.P., Moon Township, PA 15108. Made in Switzerland. 81 Count NDC: 0135-0511-05, 189 Count NDC: 0135-0511-03. 81 Ct Vial Lot # 13728 (exp 8/14), 13771 (exp 10/14), 13993  ...
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Class III Failed Lozenge Specifications; Lozenges are overly thick, overly soft, and sub and superpotent. GlaxoSmithKline Consumer Healthcare; dba-GlaxoSmithKline
Drugs Nicorette Lozenge, Nicoderm CQ, and Nicorette Gum nicotine polacrilex combination. Contains 30 Pieces/ Pallet. OTC only. GlaxoSmithKlein, 1000 GSK Drive, Moon Township, PA 15108. UPC: 0-03-0766-1442-81-2. Lot #12K16W (exp 5/14), 12K27N (exp 6/14), 12K27W (exp 6/14), 12K29N (exp 6/14), 13K20W (exp 6/15), 13K20W1 (exp 6/15) & 13K25N (exp 6/15). Class III Failed Lozenge Specifications; Lozenges are overly thick, overly soft, and sub and superpotent. GlaxoSmithKline Consumer Healthcare; dba-GlaxoSmithKline
Drugs Nicorette (nicotine polacrilex) Lozenges Mini, 2 mg, Original Flavor, 20 Lozenge, 27 Lozenge, 81 Lozenge and 135 Lozenge Vials, OTC. Distributed by GlaxoSmithKline Consumer Healthcare, LP, Moon Township, PA 15108, Made in Switzerland. 20 Count NDC: 0135-0508-04, 27 Count NDC: 0135-0508-03, 81 Count NDC: 0135-0508-02, 135 Count NDC: 0125-0508-03. (20 ct) Lot #13444 (exp 05/14), 13486 (exp 06/14), 13547 (exp 06/14), 13619 (exp 06/14), 13675 (exp 07/14), 13833 (exp 11/14), 13921 (exp 11/14), 14008 (exp 1/15), 14150 (exp 4/15), 14195 (exp 4/15), 14260 (exp 7/15), 14286 (exp 7/15), 14379 (exp 9/15), 14428 (exp 9/15), 14463 (exp9/15) & 14507 (exp  ...
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Class III Failed Lozenge Specifications; Lozenges are overly thick, overly soft, and sub and superpotent. GlaxoSmithKline Consumer Healthcare; dba-GlaxoSmithKline
Drugs Nicorette (nicotine polacrilex) Lozenges Mini, 4 mg, Original Flavor, 20 Lozenge and 81 Lozenge Vials, OTC. Distributed by GlaxoSmithKline Consumer Healthcare, LP, Moon Township, PA 15108, Made in Switzerland. 20 Count NDC: 0135-0509-04, 81 Count NDC: 0135-0509-02. (20 ct) Lot #14337 (exp 7/15), 14398 (exp 9/15) & 14510 (exp 9/15); (81 ct) Lot #14336 (exp 7/15), 14347 (exp 7/15), 14378 (9/15), 14563 (exp 9/15) Class III Failed Lozenge Specifications; Lozenges are overly thick, overly soft, and sub and superpotent. GlaxoSmithKline Consumer Healthcare; dba-GlaxoSmithKline
Drugs Nicorette Lozenge and NicoDerm CQ, nicotine polacrilex system. 189 2mg Mint Flavored Lozenges + 21 31 mg Patches. OTC Only. GlaxoSmithKlein, 1000 GSK Drive, Moon Township, PA 15108. UPC: 0-03-0766-1480-30-2. Lot #13L05N, Expiry: 8/15 Class III Failed Lozenge Specifications; Lozenges are overly thick, overly soft, and sub and superpotent. GlaxoSmithKline Consumer Healthcare; dba-GlaxoSmithKline
Devices Fassier-Duval IM Telescopic System. Orthopedic intramedullary rod implant. Catalogue number FD-040(L)-SS. -Duval IM Telescopic System. Catalogue Number: FD-040(L)-SS Lot #: 111208-03 and 110808-13 111019-01 and 110808-13 110302-01 and 110808-13 Class II The outer package label contained the incorrect length of the device. There is a label on the outer package and an additional label on the product contained in the package. Pega Medical Inc.
Devices ToxCup Drug Screen Cup, Catalogue Numbers: HT15, HT15A, PT11, PT11A, PT15A, PT23A, a screening device for the detection of drugs and drug metabolites in human urine. For in vitro diagnostic use only. Lot Numbers: O0056 O0067 N0854 O0013 O0099 O0100 O0057 O0059 O0060 O0079 Class II Branan Medical is recalling the ToxCup Drug Screen Cup because they may be labeled with incorrect result interpretation graphics on the ToxCup lid label. Branan Medical Corporation
Devices ZYM B Reagent (REF 70493). The ZYM B reagent is an additional test used to reveal the results of some miniaturized biochemical test included in the API strips. The API product line is a standardized system combining several biochemical tests, which enables group or species identifications of microorganisms. Codes - 1002706740, Exp. Date 10/14/2014, 1002717860, Exp. Date 10/24/2014, 1002742610, Exp. Date 10/30/2014, 1002760700, Exp. Date 11/4/2014, 1002821420, Exp. Date 11/26/2014, 1002857840, Exp. Date 12/12/2014, 1002860530, Exp. Date 12/12/2014 Class II bioMerieux identified a visual defect and activity issue on the ZYM B reagent (REF 70493) and FB reagent (REF 70562). The activity issue lead to a false negative result of some Rapid ID 32 strips and API biochemical tests using the ZYM B reagent or FB reagent BioMerieux SA
Devices FB Reagent (REF 70562). FB reagent is an additional test used for revealing the results of some miniaturized biochemical test included in the API and Rapid ID 32 strips. The API and ID 32 strips product lines are a standardized system combining several biochemical tests, which enables group or species identifications of microorganisms. Codes - 1002717180, Exp. Date 5/30/2014, 1002737220, Exp. Date 6/13/2014, 1002778550, Exp. Date 8/9/2014, 1002782960, Exp. Date 8/15/2014, 1002792840, Exp. Date 8/15/2014, 1002834130, Exp. Date 8/22/2014, 1002877370, Exp. Date 8/22/2014 Class II bioMerieux identified a visual defect and activity issue on the ZYM B reagent (REF 70493) and FB reagent (REF 70562). The activity issue lead to a false negative result of some Rapid ID 32 strips and API biochemical tests using the ZYM B reagent or FB reagent BioMerieux SA
Devices API NIH (REF 10400). ZYM B reagent is used and included inside of API NH (REF 10400) and API Listeria (10300). All of the API's are standardized systems combining several biochemical tests that enable group or species identification of most microorganisms. Code - 1002786740, Exp. Date 6/3/2014, 1002809140, Exp. Date 6/18/2014, 1002814890, Exp. Date 9/9/2014, 1002814891, Exp. Date 9/9/2014, 1002826750, Exp. Date 6/3/2014, 1002869720, Exp. Date 6/18/2014, 1002869721, Exp. Date 12/13/2014, 1002485910, Exp. Date 6/3/2014, 1002485911, Exp. Date 6/18/2014 Class II bioMerieux identified a visual defect and activity issue on the ZYM B reagent (REF 70493) and FB reagent (REF 70562). The activity issue lead to a false negative result of some Rapid ID 32 strips and API biochemical tests using the ZYM B reagent or FB reagent BioMerieux SA
Devices API Listeria (REF 10300). ZYM B reagent is used and included inside of API NH (REF 10400) and API Listeria (10300). All of the APIs are standardized systems combining several biochemical tests that enable group or species identification of most microorganisms. Code - 1002569040, Exp. Date 8/29/2014, 1002569041, Exp. Date 8/296/2014, 1002587190, Exp. Date 9/3/2014, 1002856790, Exp. Date 7/18/2014, 1002856800, Exp. Date 6/12/2014 Class II bioMerieux identified a visual defect and activity issue on the ZYM B reagent (REF 70493) and FB reagent (REF 70562). The activity issue lead to a false negative result of some Rapid ID 32 strips and API biochemical tests using the ZYM B reagent or FB reagent BioMerieux SA
Biologics Red Blood Cells Leukocytes Reduced W270113513474 Class II Blood product, collected from a donor who lived in an area considered endemic for malaria, was distributed. Central Pennsylvania Blood Bank
Biologics Red Blood Cells Leukocytes Reduced W270113513482, W270113588339 Class II Blood products, collected from a donor who lived in an area considered endemic for malaria, were distributed. Central Pennsylvania Blood Bank
Biologics Platelets Pooled Leukocytes Reduced W270113587483 Class II Blood products, collected from a donor who lived in an area considered endemic for malaria, were distributed. Central Pennsylvania Blood Bank
Biologics Red Blood Cells Leukocytes Reduced W204014019129 Class III Blood product, for which the entire amount of additive solution was not added during manufacturing, was distributed. American Red Cross Blood Services Heart of America Region
Biologics Platelets Pheresis Leukocytes Reduced W043814300166; W043814300161; W043814300161; W043814300161; W043814300165; W043814300165; W043814300165; W043814320100; W043814320100; W043814320105; W043814320105; W043814320105; W043814320104; W043814320104 Class III Blood products, in which quality control testing was performed, interpreted, or documented incorrectly, were distributed. LifeShare Community Blood Services
Devices Arrow Pressure Injectable PICC Powered by Arrow VPS Stylet Catalogue number CDC-35052-VPS, peripherally inserted central catheter. lot #23F14A0375 Class II Arrow is recalling the Arrow Pressure Injectable PICC Powered by Arrow VPS Stylet due to a labeling inconsistency. Arrow has received complaints for lot 23F14A0375 that kits are packaged with the incorrect catheter, specifically the kits contain a 40cm catheter and should contain a 50cm catheter. Arrow International Inc
Devices Arrowgard Blue Plus Antimicrobial Multi-lumen Central Venous Catheter, catalogue number AK-45854-CDC. lot RF2110924 Class II Arrow is recalling the Arrowgard Blue Plus Antimicrobial Multi-lumen Central Venous Catheter due to a labeling inconsistency. One portion of the lidstock states that the kit contains 8.5FR x 16CM catheter, while the rest of the lidstock correctly identifies the catheter as 8.5FR x 20CM Arrow International Inc
Biologics Red Blood Cells Leukocytes Reduced W035814018093 Class III Blood product, collected from a donor without documentation of a body temperature, was distributed. BloodSource, Inc.
Biologics Red Blood Cells (Apheresis) Leukocytes Reduced W051513043766- part 1; W051513043766-part 2 Class II Blood products, collected from a donor who had traveled to a malarial endemic area, were distributed. Innovative Blood Resources
Biologics Platelets Pheresis Leukocytes Reduced W149514940848; W149514221179 Class II Blood products, which did not meet the acceptable product specifications for release, were distributed. Northern California Community Blood Bank
Biologics Platelets Pheresis Leukocytes Reduced W149514221269-part 1; W149514221269-part 2; W149514221269-part 3 Class II Blood products, which did not meet the acceptable product specifications for release, were distributed Northern California Community Blood Bank
Devices Digital Diagnost, stationary radiographic system; Models: 712020/22/25/26/50/52/54/55/57/60/62/80/81/82/85 Units distributed from November 2006 through March 2014. Class II The footboard of Patient support for stitching can be fixed in upper position. When the fix clamp (hook) is not correctly adjusted into its correct position, the footboard is not securely held. Philips Medical Systems, Inc.
Devices Philips MDC PACS R2.X / IntelliSpace PACS DCX R3.1 software, software application that is used for receiving, managing, archiving, distributing and recording medical images onto portable digital media (including but not limited to Compact Disk and DVD). The MDC PACS/IntelliSpace PACS DCX is a software application that is used for receiving, managing, archiving, distributing and recording medical images onto portable digital media (including but not limited to Compact Disk and DVD). The MDC PACS / IntelliSpace PACS DCX receives digital images and data from various sources (including but not limited to CT, MR, US, NM, XA, RF, computed and direct radiographic devices, secondary capture devices, scanners, imaging gateways or imaging sources). Typical users of the MDC PACS /IntelliSpace PACS DCX and DIAGNET are trained medical professionals, including but not limited to radiologists, clinicians. technologist and others Software Versions: MDC PACS R2.2; R2.3 IntelliSpace PACS DCX R3.1 Class II Philips MDC PACS Release R2.x and Philips IntelliSpace PACS DCX R3.x, may have incorrect density measurement on Enhanced CT/MR examinations Philips Medical Systems, Inc.
Drugs Tikosyn® (dofetilide) 500 mcg (0.5mg) capsules, 60-count bottle, Rx only Pfizer Labs, Division of Pfizer Inc. NY, NY 10017, NDC 00069-5820-60 H48496, H48497; Exp 05/15 Class II Presence of Foriegn Tablets/Capsules: A single Tikosyn® (dofetilide) 250 mcg capsule was discovered in one bottle of Tikosyn® (dofetilide) 500 mcg (0.5 mg). Pfizer Inc.
Food Creative Snacks Co. Dried Apricots (10.5 oz Rigid Plastic Cup, and 7 oz Clear Plastic Bag), Distributed by: Creative Snacks, Co., Greensboro, NC 27409 Lot # - 2368112613 / Best Before: 07/24/2014; Lot # - 2406121313 / Best Before: 08/10/2014; Lot # - 2452010814 / Best Before: 09/5/2014; Lot # - 2481012114 / Best Before: 09/18/2014; Lot # - 7245123013 / Best Before: 07/28/2014. Class I Product contains undeclared allergen, Sulfites Creative Snacks Co., LLC
Devices Monofilament and Multifilament Non-absorbable Steel Suture; Product Codes: 0520197-2, 29-727, 29-7270M4, 29-7281M4, E29-5553M4, E29-7270M4, E29-7272M4, E29-727A, EP4013P, EP4110N, X-2235, X29-7271M2, X-5667M8 and X-6730M5. Product Code: 0520197-2, Lot number: 02H1001071; Product Code: 29-727, Lot numbers: 02M1101954, 02C1201003, and 02C1201646; Product Code: 29-7270M4, Lot number: 02D1100604; Product Code: 29-7281M4, Lot number: 02M1002679; Product Code: E29-5553M4, Lot number: 02B1300245; Product Code: E29-7270M4, Lot number: 02J1001576; Product Code: E29-7272M4, Lot number: 02D1003015; Product Code: E29-727A, Lot number:  ...
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Class II The products are being recalled because they did not meet minimum diameter requirements. Teleflex Medical
Devices On-Board Imager - Exact Arm Elbow Motor Shaft (kVD, kVS, and MV) with ''Type 01" elbow motors. Product Usage: The On-Board Imager device is an x-ray device used for evaluation of correct patient position in relation to isocenter and verification of treatment fields in relation to anatomical and fiducial landmarks. Model H08: Code numbers: H080002 H080065 H080126 H080187 H080251 H080314 H080378 H080441 H080503 H080607 H080672 H080749 H080944 H080003 H080066 H080127 H080188 H080252 H080315 H080379 H080442 H080504 H080608 H080673 H080753 H080947 H080004 H080068 H080128 H080189 H080254 H080316 H080380 H080443 H080506 H080609 H080674 H080754 H080948 HOSOOOS H080069 H080129 H080190 H0802SS H080317 H080381  ...
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Class II Varian has identified a failure with the shaft of the Type 01 elbow motor for Exact arms used in the On-Board Imager (OBI) device due to belt over-tensioning. Varian Medical Systems, Inc.
Devices GE Vivid E9 Ultrasound System, a general-purpose ultrasound system, specialized for use in cardiac imaging. Mfg Lot or Serial # System ID 0000000VE90667 VE9000667 0000000VE90680 VE9000680 0000000VE90878 VE9000878 0000000VE91045 VE9001045 0000000VE91821 VE9001821 0000000VE91826 VE9R001826 0000000VE92470 VE9R002470 0000000VE93780 VE9R003780 0000000VE94119 VE9R004119 0000000VE94120 VE9R004120 0000000VE94291 VE9R004291 0000000VE94521 VE9004521 0000000VE94736 VE9R004736 0000000VE94790 VE9R004790 0000000VE94876 VE9R004876 0000000VE95024 VE9R005024 0000000VE95025 VE9R005025 0000000VE95027 VE9R005027 0000000VE95028 VE9R005028 0000000VE95222 VE9R005222 0000000VE95226 VE9R005226 0000000VE95271  ...
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Class II GE Healthcare has recently become aware of a potential safety issue where the probe power surveillance settings for 4 probes (C1-5-D, C2-9-D, IC5-9-D and M5Sc-D) are incorrect. This may result in a situation where probes can overheat. GE Healthcare, LLC
Devices GE Healthcare, Discovery MR450, Discovery MR750, Optima MR450w, Optima MR 450w GEM, Discovery MR750w, and Discovery MR750w GEM products. Magnetic Resonance Diagnostic Device. FMI 60865 (DV Family Gradient Connections) Mfg Lot or Serial # SystemID 00001250FMM026 919684DMPMR1 00000301309MR1 6628 00000000HM0426 6947 00000305379MR0 7462 00001018XF503B 205592750 00001227FMM00T 201445750W 00000297006MR9 202476MR1 00000296307MR2 202476MR2 00000297727MR0 202476MR3 00000300562MR6 202476MR4 00000000UA0153 202966MR3TW 00000305414MR5 203739MR450W 00000301842MR1 203863MR450W 00001203FMMOUJ 205750MR5 00000298836MR8 205838MR4 00000298249MR4 205949MR450W 00000301841MR3 206292SR450W 00000000UA0026 206292SR750W 00000293338MR0 206CH750MR  ...
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Class II GE Healthcare has recently become aware of a potential safety issue with gradient coil electromechanical connections associated with GE MR Products. Gradient coil electromechanical connections may loosen causing an increase in resistance. The increased resistance can lead to increasing heat during scanning which, in turn, can cause material in the Rear Endbell enclosure to overheat, generate smoke in the scan room, and cause some localized melting of the Endbell. This overheating has occurred only while units were being serviced by GE service engineers during repeated evaluation scanning. However, the issue could also occur in Clinical mode. GE Healthcare, LLC
Food Sprouts Farmers Market Organic Whole Black Peppercorns, 2.12oz., UPC Code 8-74875-00425-4, Lot Numbers 3287 and 3246. Packaged in glass jars with plastic lid. Product labeling reads in part:"SPROUTS FARMERS MARKET organic Black Peppercorns ***NET WT 2.12 OZ (60g)***Manufactured Exclusively For Sprouts Farmers Market Phoenix, Arizona 85028***www.sprouts.com***SP00056***8 74875 00425 4***". UPC Code 8-74875-00425-4, Lot Numbers 3287 and 3246. Expiration 10/2016 (Lot 3287) and 09/2016 (Lot 3246). Class I Sprouts Farmers Market, Inc. is recalling Organic Whole Black Peppercorns, Lot 3287 after FDA test results revealed the presence of Salmonella and Lot 3246 as precaution because it has the potential to be contaminated with Salmonella. Sprout's Farmers Market
Food 1) Frontier Natural Products Co-op, Whole Black Peppercorns, Certified Organic, Piper nigrum. Net 11.3 Kg 25 LB. Packaged in corrugated cardboard boxes. Firm name on the label is Frontier in Norway, IA. UPC 0-89836-82603-9.; 2) Frontier Natural Products Co-op, Whole Black Peppercorns, Certified Organic, Piper nigrum. Net 453 g 16 OZ. Packaged in foil pouches. Firm name on the label is Frontier in Norway, IA. UPC 0-89836-02603-3; 3) Frontier Natural Products Co-op, Black Peppercorns Whole. Net WT. 2.12 OZ (60 g). Packaged in glass jars. Distributed by Frontier Natural Products Co-op, Norway, IA. UPC 0-89836-18435-1; 4) Simply Organic, black peppercorns. NET WT. 2.65 OZ. (75g). Packaged in glass jars. Distributed by Frontier Natural Products, Norway, IA. UPC 0-89836-18524-2.; 5) Simply Organic, Adjustable Grinder Cap, daily grind. NET WT. 2.65 OZ. (75g). Packaged in glass jars with a grinder cap. Distributed by Frontier Natural Products, Norway, IA. UPC 0-89836-19218-9.; 6) Simply Organic, black peppercorns, poivre noir en grains. NET WT. 2.65 OZ. POID NET 75g. Packaged in glass jars. Manufactured by Frontier Natural Products, Norway, IA. UPC 0-89836-19210-3.; 7) Simply Organic, Adjustable Grinder, Broyeur Réglable, black peppercorns, poivre noir en grains. NET WT. 2.65 OZ. POID NET 75g. Packaged in glass jars. Manufactured by Frontier Natural Products, Norway, IA. UPC 0-89836-19218-9.; 8) 365, Black Peppercorns, NET WT 1.87 OZ (53g). Packaged in glass jars. Distributed by Whole Foods Market, Austin Texas. UPC 0-99482-44497-6; 9) 365, Black Peppercorns, NET WT 2.12 OZ (60g). Packaged in glass jars. Distributed by Whole Foods Market, Austin Texas. UPC 0-99482-44563-8.; 10) 365, Black Peppercorns, NET WT 8.08 OZ (229g). Packaged in glass jars. Distributed by Whole Foods Market, Austin Texas. UPC 0-99482-44511-9.; 11) 365, Organic Black Peppercorns Grains de Poivre noir biologique, 60g (2.12 OZ). Packaged in glass jars. Distributed by Whole Foods Market, Austin Texas. UPC 0-99482-73914-0; 12) Nature's Place Organic, Black Peppercorns, NET WT. 2.26 OZ (64g). Packaged in glass jars. Distributed by DZA Brands, LLC in Salisbury, NC. UPC 7-25439-95273-6; 13) Meijer Organics, Black Peppercorns, NET WT. 2.26 OZ (64g). Packaged in plastic jars. Item number ME81732. UPC 7-13733-78173-2; Lot numbers: 3246, 3226, 3256, 3288, 3232, 3233, 3280, 3246, 3287, 3260, 3267, 3247, 3221, 3262, 3294, and 3261; Class I Testing of organic whole black peppercorns revealed the presence of Salmonella Frontier Natural Products Co-op
Devices iLab Ultrasound Imaging System; iLab 3.0 (Polaris 1.0) software. Used for ultrasound examinations of intravascular pathology. Model Numbers: H749ILAB120CART0 H749ILAB120INS0 H749ILAB120N2710 Serial numbers: 4219, 4900, 5701, 5827 7516, 7517, 7607 8407, 8434. the different UPNs represent minor level differences in configuration relative to mobility and no difference in any essential components or software. Class II Specific iLab Ultrasound Imaging Systems using newest 3.0 (Polaris 1.0) software change the pullback speed from the default setting of 0.5 mm/sec to 1.0 mm/sec, the Longview distance measurement may display an inaccurate value that is double the actual distance. Boston Scientific Corporation
Food Lisy Sweet Basil Albahaca Net WT/Cont. Neto 6oz. (171g) Item 1132 www.lisycorp.com Packed on a clear plastic container with a UPC # 0 96786 30032 8 Item 1132 Lot #'s A013 0518 and A014 0518 Class I FDA sample collected was found to be positive for salmonella spp. Lisy Corp.
Food Natural Grocers by Vitamin Cottage, Pepper Black Whole Organic, about 0.30 lb, UPC 201046804762, packaged in plastic bags. Pack on dates: 28-14, 13-14, 351-13, 336-13, 322-13, 305-13, 290-13, 281-13, 266-13, 252-13, 245-13 Class I Vitamin Cottage Natural Food Markets, Inc., a Lakewood, Colorado based natural grocery chain, is recalling multiple lots of Natural Grocers brand Organic Black Peppercorns as the product has the potential to be contaminated with Salmonella. Natural Grocers by Vitamin Cottage
Devices Amo-O Herbal Stimulator, 2 fl. oz. Manufactured by Meta Labs, UPC Code 80702-1 Product Usage: The product is a nonprescription, topical gel that is used to enhance libido and stimulate orgasmic pleasure. Lot 8-94034 Class II Firm is not registered as a drug manufacturer. Altasource LLC dba Meta Labs LLC
Devices Mega-Gen His Personal Lubricant, 8 fl. oz., Meta Labs, UPC Code 80708-3; Mega-Gen Hers Personal Lubricant, 8 fl. oz., Meta Labs, UPC Code 80808-0 Product Usage: A topical gel that increases sexual excitement and pleasure. Lot 8-94034 Class II Firm is not registered as a drug manufacturer. Altasource LLC dba Meta Labs LLC
Devices Nice-En-Smooth Berry Burst, 4 oz., Manufactured by Meta Labs LLC, UPC 80604-8 Product Usage: Flavored lubricant water based, condom friendly jelly used to enhance or replace a womans natural lubrication. Lot 8-94034 Class II Firm is not registered as a drug manufacturer. Altasource LLC dba Meta Labs LLC
Devices Hot Ice, 1 fl. oz., Meta Labs LLC, UPC 80705-2 Product Usage: A topical gel that increases men and womens sexual excitement and pleasure. Lot 8-94034 Class II Firm is not registered as a drug manufacturer. Altasource LLC dba Meta Labs LLC
Food Jolly Time Microwave popcorn, Butter, 3/3-oz bags/carton. The cartons are packaged 12-cartons/case. Individual carton UPC 028190007876, on the 12-ct case - UPC 10028190007804 and 48-ct case UPC 128190487873 American Pop Corn Company, Sioux City, IA. Best By 03/27/15 (Julian date) 4086 Class II The product has the potential to be contaminated with stainless steel metal fragments. American Pop Corn Co
Food Jolly Time Microwave popcorn, Extra Butter, 3/3-oz bags/carton. The cartons are packaged 12-cartons/case. Individual carton - UPC 028190008477, on the 12 count case - UPC 10028190008474 and 48 ct shipper with UPC 128190488474 American Pop Corn Company, Sioux City, IA. Best By 03/31/15 (Julian date) 4090 Class II The product has the potential to be contaminated with stainless steel metal fragments. American Pop Corn Co
Food Jolly Time Microwave popcorn, Homemade Classic Stovetop Flavor, 3/3-oz bags/carton. The cartons are packaged 12-cartons/case. Individual carton - UPC 028190007807, on the 12-ct case - UPC 10028190007804, 48-ct shipper UPC 128190487804 American Pop Corn Company, Sioux City, IA Best By code of 04/01/15 (Julian date) 4091 Class II The product has the potential to be contaminated with stainless steel metal fragments. American Pop Corn Co
Food Cinnamon Cookie Manjoo, 200g Net Weight. Packaged in clear plastic bag, 10 per bag. Product package labeled in part:"***Cinnamon Cookie (Manjoo)*** Net Wt. 200g, 7.1oz***Manufactured by: CJ Foodville USA, Inc. (323)480-9105***6834 E. Slauson Ave, Commerce, CA 90040***2229039219***. Production batch: 1/1/2013-03/13/2014. No codes on finished packaging. Class II CJ Foodville USA, Inc. is recalling its chocolate madeline, madeline, and cinnamon cookie manjoo because the product labels do not declare the food allergen wheat. CJ Bakery, INC
Food Madeline, 80g Net Weight. Packaged in clear plastic bag, 4 per bag. Product package labeled in part:"AUTHENIC BAKERY TOUS Les JOURS***Madeline*** Net Wt. 80g, 2.8oz ***Manufactured by: CJ Foodville USA, Inc. (323)480-9105***6834 E. Slauson Ave, Commerce, CA 90040***2229039249***. Production batch: 1/1/2013-03/13/2014 No codes on finished package. Class II CJ Foodville USA, Inc. is recalling its chocolate madeline, madeline, and cinnamon cookie manjoo because the product labels do not declare the food allergen wheat. CJ Bakery, INC
Food Chocolate Madeline, 80g Net Weight. Packaged in clear plastic bag, 4 per bag. Product package labeled in part:"AUTHENIC BAKERY TOUS Les JOURS***Madeline*** Net Wt. 80g, 2.8oz ***Manufactured by: CJ Foodville USA, Inc. (323)480-9105***6834 E. Slauson Ave, Commerce, CA 90040***2229039249***. Production batch: 1/1/2013-03/13/2014 No codes on finished package. Class II CJ Foodville USA, Inc. is recalling its chocolate madeline, madeline, and cinnamon cookie manjoo because the product labels do not declare the food allergen wheat. CJ Bakery, INC
Drugs Day Time Cold & Flu, Multi-Symptom, Non-Drowsy, Acetaminophen, Dextromethorphan HBr, Phenylephrine HCl, 4, 6, 8, 10, and 12 oz Bottles, OTC Only. Labeled A) Aaron Health, 10 FL OZ, Manufactured by Aaron Industries, P.O. Box 801, Lynwood, CA 90262, UPC: 7 15256 73510 0; B) Aaron Health, 8 FL OZ, Manufactured by: PL Developments, 11865 S. Alameda St, Lynwood, CA 90262, UPC: 7 15256 71428 0; C) Aaron Brands, 6 FL OZ, Manufactured by: Aaron Industries, Inc., P.O. Box 801, Lynwood, CA 90262, UPC: 7 15256 73506 3; D) Aaron Health, 4 FL OZ, Manufactured by: Aaron Industries, P.O. Box 801, Lynwood, CA 90262, UPC: 7 15256 73504 9; E) Best Choice, 6 FL OZ, Proudly Distributed By: Valu Merchandisers, CO., Kansas City, MO 64111, UPC: 0 70038 61984 0 F) Best Choice, 10 FL OZ, Proudly Distributed By: Valu Merchandisers, Co., 5000 Kansas Ave, Kansas City, KS 66106, UPC: 0 70038 61985; G) CareOne, 10 FL OZ, Distributed By American Sales Company, 4201 Walden Avenue, Lancaster, NY 14086, UPC: 3 41520 31853 5; H) CareOne, 12 FL OZ, Distributed By: American Sales Company, 4201 Walden Avenue, Lancaster, NY 14086, UPC: 3 41520 31832 0; I) drug mart, 10 FL OZ, Distributed By: Discount Drug Mart-Food Fair, Medina, Ohio 44256, NDC: 93351-0142-1; J) DR, 6 FL OZ, Distributed by DUANEreade, 440 Ninth Avenue, NY, NY 10001, UPC: 6 39194 04479; K) DR, 10 FL OZ, Distributed by DUANEreade, 440 Ninth Avenue, NY, NY 10001, UPC: 6 39194 04480 6; L) equate, 10 FL OZ, Distributed by: Wal-Mart Stores, Inc., Bentonville, AR 72716, NDC: 49035-142-01; M) equate: 12 FL OZ, Distributed by: Wal-Mart Stores, Inc., Bentonville, AR 72716, NDC: 49035-142-02; N) exchange select, 10 FL OZ, Manufactured For: Your Military Exchanges, By Aaron Industries Inc., P.O. Box 801, Lynwood CA 90262, UPC: 6 14299 40234 8; O) Family wellness, 10 FL OZ, Distributed By: Family Dollar Services, Inc., 10401 Monroe Rd, Matthews, NC 28105 USA, UPC: 0 32251 00504 6; P) Fred's, 10 FL OZ, Distributed By: Fred's, Inc., 4300 New Getwell Rd, Memphis, TN 38118, UPC: 0 84579 11020 9; Q) Laura Lynn, 6 FL OZ, Distributed by: Ingles Markets, Asheville, NC 28816, UPC: 0 86854 04767 5; R) LiveBetter, 10 FL OZ, Distributed By Onpoint, Inc., 2 Paragon Drive, Montvale, NJ 07645, NDC: 49580-3416-1; S) LiveBetter, 6 FL OZ, Distributed By Onpoint, Inc., 2 Paragon Drive, Montvale, NJ 07645, NDC: 41310-0142-6; T) Marc's, 10 FL OZ, Distributed by: Marc Glassman Inc. Manufactured by: Aaron Industries, Inc., P.O. Box 801, Lynwood, CA 90262, UPC: 7 15256 73510 0; U) 666 COLD Preparation, 4 FL OZ, Distributed by: Monticello Drug Company, Jacksonville, FL 32204, UPC: 3 11868 00224 3; V) 666 COLD Preparation, 8 FL OZ, Distributed by: Monticello Drug Company, Jacksonville, FL 32204, UPC: 3 11868 00228 1; W) Our Family, 12 FL OZ, Distributed By: Nash Finch Company, NFC Brands, 7600 France Ave S, MPLS, MN 55435, UPC: 0 70253 97109 9; X) Our Family, 10 FL OZ, Distributed By: Nash Finch Company, NFC Brands, 7600 France Ave S, MPLS, MN 55435, UPC: 0 70253 96745 0; Y) Premier Value, 6 FL OZ, Distributed By: Chain Drug Consortium, LLC., 2300 NW Corporate Blvd., Suite 115, Boca Rataon, FL 33431, NDC: 68016-0023-79; Z) Premier Value, 8 FL OZ, Distributed By: Chain Drug Consortium, 3301 NW Boca Raton Blvd, Suit 101, Boca Raton, FL 33431, NDC: 68013-142-08; AA) Premier Value, 10 FL OZ, Distributed By: Chain Drug Consortium, 3301 NW Boca Raton Blvd, Suit 101, Boca Raton, FL 33431, NDC: 68013-142-01; BB) Publix, 10 FL OZ, Distributed By: Publix Super Markets, Inc., 3300 Publix Corporate Parkway, Lakeland, FL 33811, 0 41415 27073 2; CC) Quality Choice, 8 FL OZ, Distributed by C.D.M.A. Inc., 43157 W. Nine Mile, Novi, MI 48376, NDC: 63868-245-08; DD) Quality Choice, 10 FL OZ, Distributed by Quality Choice, Novi, MI 48376, NDC: 63868-0245-10; EE) Quality Choice, 12 FL OZ, Distributed by C.D.M.A. Inc., 43157 W. Nine Mile, Novli, MI 48376, NDC: 63868-245-12; FF) Rite Aid, 6 FL OZ, Distributed By: Rite Aid, 30 Hunter Lane, Camp Hill, PA 170 Lot # (expiry): Aaron Health A-D) 72493 (5/14), 75241 (7/14), 77879 (8/14), 78795 (9/14), 81058 (11/14), 81118 (10/14), 81578 (10/14), 82076 (10/14), 82023 (11/14), 140756 (1/15), 141655 (11/14), 141882 (3/15), 142086 (2/15), 144257 (1/15), 147361 (3/15), 148288 (6/15), 149143 (7/15), 149512 (7/15), 149741 (8/15), 150307 (9/15), 152290 (3/15), 152666 (11/15),  ...
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Class III Subpotent Drug: Phenylephrine component is subpotent. P&L Developments, LLC
Devices Siemens ACUSON X700 Ultrasound Systems with software version 1.0.00, 1.0.01, 1.0.02, 1.1.00 and 1.1.02. ultrasound imaging system. Model numbers: 1065844  ACUSON X700 Ultrasound System 10658846 - ACUSON X700 Ultrasound System (Russia) 10658845 - ACUSON X700 Ultrasound System (Korea) Class II When fourSight 4D ultrasound imaging, 3-Scrape real time 3D imaging, or Anatomical M-mode are used during an Obstetric or Gynecology study, data from the previous patient could replace the current patient's date in the report. Siemens Medical Solutions USA, Inc.
Devices ev3 EverCross 0.035" OTW PTA Dilatation Catheter, 6mm x 120mm x 135cm, REF: AB35W06120135. and ev3 EverCross 0.035" OTW PTA Dilatation Catheter, 6mm x 40mm x, 80cm REF: AB35W06040080. Peripheral Dilatation Catheter AB35W06120135 Lot: 9855406 Use by: 2017-01-16 AB35W06040080 Lot: 9852591 Use by: 2017-01-16 Class II Covidien is recalling 2 production lots of EverCross 0.035 PTA Balloon Catheter because of a product labeling error. There is a discrepancy in the PTA Balloon length and the delivery catheter length printed on the product labeling. Ev3, Inc.
Devices Merit Laureate Hydrophilic Guide Wire, Catalog No. LWSTFS35260EX, Straight Tip Stiff Shaft, 0.035" (0.89mm), 260 cm (102"). Lot No. K556399, Expires 2016-10 Class II Discrepancy between the carton and unit labeling for the Merit Laureate Hydrophilic 0.035" 260 cm Guide Wire, catalog number LWSTFS35260EX, which has a straight tip and a stiff shaft. This lot was partially mixed with another lot of Laureate 0.035" 260 cm Guide Wire, catalog number LWSTDA35260EX, which has an angled tip, standard shaft and Chinese unit labeling. Merit Medical Systems, Inc.
Devices Merit Laureate 0.035" (0.89mm) Hydrophilic Guide Wire, Angled Tip, Standard Shaft, Catalog No. LWSTDA35260EX, 260 cm (102"). Lot No. K556402, Expires 2016-10 Class II Merit Medical Systems, Inc. is voluntarily conducting a recall due to a discrepancy between the carton and unit labeling for the Merit Laureate Hydrophilic 0.035" 260 cm Guide Wire, catalog number LWSTFS35260EX, lot number K556399 (173 units), which has a straight tip and a stiff shaft. Lot K556399 was partially mixed with another lot of Laureate 0.035" 260 cm Guide Wire, catalog number LWSTDA35260EX, lot number K556402 (186 units), which has an angled tip, standard shaft and Chinese unit labeling. Merit Medical Systems, Inc.
Drugs Oxandrolone Tablets, USP, 10 mg, Rx Only, C-III, 60-count bottle, Manufactured for: Upsher-Smith Labs, Minneapolis, MN 55447, by: Pharmaceutics International, Inc., Hunt Valley, MD 21031, NDC 0245-0272-06 Lot #2802.042A, Exp. 10/2015 Class III Labeling: Missing Label; Three cases of product (total of 36 bottles) were packaged without the primary label on the bottle. The cases were, however, packaged in the correct finished product shipper, labeled with the correct shipper bar code label, sealed with tamper-evident tape and erroneously shipped to Upsher-Smith. Upsher Smith Laboratories, Inc.
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