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FDA Recalls
›Drug Recalls

FDA Drug Recalls

Recalls of prescription drugs, over-the-counter medications, and compounded pharmaceuticals.

Classification

All Class I Class II Class III

Status

All Ongoing Completed Terminated

Date

All time Past 30 days Past 12 months

Showing 7661–7680 of 17,773 recalls

Class IITerminated

INODERM Antiseptic Hand Soap (E-2), .6% (incorrectly labeled on bags as 75%) PCMX, 800ml/27fl.oz.pouches (NDC 058575-110), 12 x 800 Bag-N-Box pouches per case (NDC 058575-110-80), 5014-404-NB; INOPAK, 24 Executive PKWY, Ringwood, NJ 07456.

Inopak Ltd

CGMP Deviations: hand sanitizers and soaps were not produced under current good manufacturing practices.

April 22, 2019 · DrugView details →

Class IITerminated

Antibacterial Hand Soap, Healthcare 2000, labeled as a) DERMA System CARE SaniClenz Antimicrobial Skin Cleanser (Chlorhexidine Gluconate), 4 x (1 gallon containers), Reorder/REF #JSCG; Manufactured for Crosstex International, Inc.; b) MEDI-WASH CHG Anti-Microbial Hand Wash with Chlorhexidine Gluconate; 1000ML pouches, 8/1000ML pouches per case, Walter G. Legge Co Inc, 444 Central AVE, Peekskill, NY 10566

Inopak Ltd

CGMP Deviations: hand sanitizers and soaps were not produced under current good manufacturing practices.

April 22, 2019 · Drug

View details →

Class IITerminated

Instant Waterless Hand Sanitizer, Ethyl Alcohol, 62%, packaged as a) DermaGel Instant Waterless Hand Sanitizing Gel with Moisturizers, with Aloe Vera & Vitamin E, packaged in a) 1000 ml Disc Pump pouches (NDC 58575-340), 8 x 1000 ml Disc Pump pouches per case, Product Code 5025-L1000; b) 2 fl. oz. bottles, 80/2 oz bottles per case, 5025-480-02; c) 18 fl. oz. bottles (NDC 58575-340), 16/18 oz bottles per case, 5025-430-02; d) 8 FL OZ. bottle, 24/8 oz bottle per case, 5025-440-03; e) 4 fl. oz. bottles, 24 x 4oz. Bottles per case, 5025-450-03; f) 800 ml pouches, 12 x 800 ml Universal Valve pouches per case, 5025-404-NB; g) 1 Gallon bottles, 4/1 gallon bottles per case, 5025-4202-02; Inopak LTD., Ringwood, NJ 07456. SaniTyze Hand Sanitizer with Aloe Vera, Vitamin E & Keratin, packaged as h) 8 fl oz (237 ml) bottles, 24/ 8 Oz. bottles per case; Manufactured for Crosstex International, Inc., 10 Rarick Road, Hauppague, NY 11788-4209.

Inopak Ltd

CGMP Deviations: hand sanitizers and soaps were not produced under current good manufacturing practices.

April 22, 2019 · DrugView details →

Class IITerminated

Sani-Guard-SF Waterless Foam Hand Sanitizer, Ethyl Alcohol 70%, packaged in a) 6/1000 ml pouches per case, 5068-FL1000, b) 1000 ml cartridge pouch, 6/1000 ml .8ml Option Cartridge pouches per case, 5068-OS1000, Inopak LTD

Inopak Ltd

CGMP Deviations: hand sanitizers and soaps were not produced under current good manufacturing practices.

April 22, 2019 · DrugView details →

Class IIITerminated

Carvedilol Tablets, USP, 3.125 mg, 500-count bottle, Rx Only, Manufactured by: Cadila Healthcare Ltd., India; Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534; NDC 68382-092-05

Zydus Pharmaceuticals USA Inc

Presence of Foreign Tablets/Capsules: Customer complaint for a small, solid, light yellow substance, identified as a fragmented tablet of another drug product, found mixed with tablets in a bottle of Carvedilol tablets 3.125mg.

April 22, 2019 · DrugView details →

Class IITerminated

ANTIBACTERIAL Foaming Hand Wash With Moisturizers labeled as Antibacterial Foaming Soap, ACTIVE:P.C.M.X, packaged in a) 18 oz bottles, 12/18 oz bottles per case, 5063-432-02; b) 1 gallon bottles, 4/1 gallon bottles per case, 5063-420-03; c) Options Systems Antibacterial Foaming Hand Wash with .3% PCMX, packaged in 1000mL pouches, 6/1000ML pouches per case, 5063-OS1000; d) INOFOAM Antibacterial Foaming Hand Wash with .3% PCMX, packaged in 1000mL pouches, 6-1000ml pouches per case, 5063-FL1000, Inopak LTD., 24 Executive Parkway, Ringwood, NJ 07456.

Inopak Ltd

CGMP Deviations: hand sanitizers and soaps were not produced under current good manufacturing practices.

April 22, 2019 · DrugView details →

Class IITerminated

AQUACIL instant foaming hand sanitizer, alcohol free formula, benzalkonium chloride 0.1% (w/w), packaged in a) 18 FL OZ (532 mL) bottles, 12/18OZ bottles per case, Product Code BIO-5075-432-02; b) 1000 ML pouches, 6/1000 ML pouches per case, Product Code BIO575-OS1000, Biocentris Pharmaceuticals (Division of Inopak).

Inopak Ltd

CGMP Deviations: hand sanitizers and soaps were not produced under current good manufacturing practices.

April 22, 2019 · DrugView details →

Class IITerminated

Losartan Potassium/HCTZ, 100 mg/12.5 mg Tablet, 90-Count bottle, Manufactured by Torrent Pharmaceuticals, Distributed by RemedyRepack, Inc. Indiana, PA, 15701-3570, NDC 70518-1560-00.

RemedyRepack Inc.

CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable daily intake level of 0.96 parts per million.

April 22, 2019 · DrugView details →

Class ITerminated

FENTANYL Transdermal System, 12 mcg/h, five (12 mcg/h) systems per carton, Rx only, Distributed by: Alvogen, Inc., Pine Brook, NJ 07058; Manufactured by: 3M Drug Delivery Systems, St. Paul, MN 55107, NDC 47781-423-47.

Alvogen, Inc

Product Mix-Up: Customer complaint that their carton labeled as Fentanyl Transdermal Systems, 12 mcg/h contained five patches labeled and containing 50 mcg/h.

April 19, 2019 · DrugView details →

Class IITerminated

BEVACIZUMAB 1.25 mg/0.05 mL 31G MJ syringe Intravitreal Injection. This biologic product was repackaged by AmEx Pharmacy 1515 Elizabeth St. Suite J Melbourne, FL 32901 Lot:190212AB BUD:5/13/2019, Repackaged on 2/12/2019

Pacifico National, Inc. dba AmEx Pharmacy

Defective Delivery System: difficult to express

April 19, 2019 · DrugView details →

Class IIOngoing

Losartan Potassium Tablets, USP, 100 mg, a) 90-count (NDC: 13668-115-90), b)1000-count (NDC: 13668-115-10) per bottle, Rx only, Manufactured by: Torrent Pharmaceuticals LTD, Indrad-382 721, Dist. Mehsana India

Torrent Pharma Inc.

CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable daily intake level.

April 18, 2019 · DrugView details →

Class IIOngoing

Losartan Potassium Tablets, USP, 25 mg, a) 90-count (NDC: 13668-113-90), b)1000-count (NDC: 13668-113-10) per bottle, Rx only, Manufactured by: Torrent Pharmaceuticals LTD, Indrad-382 721, Dist. Mehsana India

Torrent Pharma Inc.

CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable daily intake level.

April 18, 2019 · DrugView details →

Class IIOngoing

Losartan Potassium and Hydrochlorothiazide Tablets, USP, 50mg/12.5mg, a) 30-count (NDC: 13668-116-30), b) 90-count (NDC: 13668-116-90), c) 1000-count (NDC: 13668-116-10), per bottle, Rx only, Manufactured by: Torrent Pharmaceuticals LTD, Indrad-382 721, Dist. Mehsana India

Torrent Pharma Inc.

CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable daily intake level.

April 18, 2019 · DrugView details →

Class IIOngoing

Losartan Potassium and Hydrochlorothiazide Tablets, USP, 100mg/25mg, a) 30-count (NDC: 13668-118-30) b) 90-count (NDC: 13668-118-90), c) 1000-count (NDC: 13668-118-10), per bottle, Rx only, Manufactured by: Torrent Pharmaceuticals LTD, Indrad-382 721, Dist. Mehsana India

Torrent Pharma Inc.

CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable daily intake level.

April 18, 2019 · DrugView details →

Class IIOngoing

Losartan Potassium Tablets, USP, 50 mg, a) 90-count (NDC: 13668-409-90), b)1000-count (NDC: 13668-409-10) per bottle, Rx only, Manufactured by: Torrent Pharmaceuticals LTD, Indrad-382 721, Dist. Mehsana India

Torrent Pharma Inc.

CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable daily intake level.

April 18, 2019 · DrugView details →

Class IIOngoing

Losartan Potassium and Hydrochlorothiazide Tablets, USP, 100mg/12.5mg, a) 90-count (NDC: 13668-117-90), b) 1000-count (NDC: 13668-117-10), per bottle, Rx only, Manufactured by: Torrent Pharmaceuticals LTD, Indrad-382 721, Dist. Mehsana India

Torrent Pharma Inc.

CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable daily intake level.

April 18, 2019 · DrugView details →

Class IITerminated

Volumex (Iodinated I 131 Albumin) Injection USP, 25 uCi per 1 mL syringe, Rx Only, Manufactured for Daxor Corp., NY, NY; By: Iso-Tex Diagnostics, Inc.; NDC 50914-7720-8.

Iso-Tex Diagnostics, Inc

Lack of Assurance of Sterility: environmental monitoring report exceeds limits, therefore sterility cannot be assured.

April 15, 2019 · DrugView details →

Class IITerminated

Chlorothiazide 100 mg, 3.57 mL syringe, Made by: Enterprise Pharmacy, 4400 Golf Acres Drive, Bldg. J Suite E, Charlotte, NC, 28208.

CMC Enterprise Pharmacy

Lack of sterility assurance.

April 12, 2019 · DrugView details →

Class IITerminated

CeFAZolin 2 GM a) in NS 100 mL bag; b) 100 mg/mL (20 mL) syringe, Made by: Enterprise Pharmacy, 4400 Golf Acres Drive, Bldg. J Suite E, Charlotte, NC, 28208.

CMC Enterprise Pharmacy

Lack of sterility assurance.

April 12, 2019 · DrugView details →

Class IITerminated

Dexmedetomidine 400 mcg in NS 100 mL bag, Made by: Enterprise Pharmacy, 4400 Golf Acres Drive, Bldg. J Suite E, Charlotte, NC, 28208.

CMC Enterprise Pharmacy

Lack of sterility assurance.

April 12, 2019 · DrugView details →

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