November 24, 2021DrugsFDA
Bayer Healthcare Pharmaceuticals Inc. recalls Tinactin (Tolnaftate 1%) JOCK ITCH POWDER SPRAY NET WT133g (4.6 oz) can, Dist by: Bayer Healthcare LLC, Whippany, NJ 079
Hazard: Chemical Contamination: presence of benzene
November 24, 2021DrugsFDA
Bayer Healthcare Pharmaceuticals Inc. recalls Tinactin (Tolnaftate 1%) LIQUID SPRAY NET WT150g (5.3 OZ) can, Labeled as (a) Product of Finland 20006101, (b) Product
Hazard: Chemical Contamination: presence of benzene
November 24, 2021DrugsFDA
Bayer Healthcare Pharmaceuticals Inc. recalls Tinactin (Tolnaftate 1%) DEODORANT POWDER SPRAY NET WT 133g (4.6 OZ) can, Dist by: Bayer Healthcare LLC, Whippany, NJ 07
Hazard: Chemical Contamination: presence of benzene
November 24, 2021DrugsFDA
Bayer Healthcare Pharmaceuticals Inc. recalls Lotrimin AF (Tolnaftate 1%) Daily Prevention deodorant powder spray, NET WT 160g (5.6 OZ) can, Dist by: Bayer Healthcare
Hazard: Chemical Contamination: presence of benzene
November 24, 2021DrugsFDA
Bayer Healthcare Pharmaceuticals Inc. recalls LOTRIMIN AF, (Miconazole nitrate 2%), Powder Spray, NET WT 133g (4.6 OZ) can, Dist by: Bayer Healthcare LLC, Whippany, N
Hazard: Chemical Contamination: presence of benzene
November 24, 2021DrugsFDA
Bayer Healthcare Pharmaceuticals Inc. recalls LOTRIMIN AF, (Miconazole nitrate 2%), Jock Itch, Powder Spray, NET WT 133g (4.6 OZ) can, Dist by: Bayer Healthcare LLC,
Hazard: Chemical Contamination: presence of benzene
November 24, 2021DrugsFDA
Bayer Healthcare Pharmaceuticals Inc. recalls LOTRIMIN AF (Miconazole nitrate 2%) Deodorant Powder Spray, NET WT 133g (4.6 OZ) can, Dist by: Bayer Healthcare LLC, Whi
Hazard: Chemical Contamination: presence of benzene
November 24, 2021DrugsFDA
Bayer Healthcare Pharmaceuticals Inc. recalls Tinactin (Tolnaftate 1%) POWDER SPRAY NET WT 133g (4.6 oz) can, Labeled as (a) Product of Ireland 86940418, (b)Product
Hazard: cGMP Deviations: manufactured at the same facility where other lots were found to be contaminated with benzene.
November 24, 2021DrugsFDA
Bayer Healthcare Pharmaceuticals Inc. recalls Tinactin (Tolnaftate 1%) JOCK ITCH POWDER SPRAY NET WT133g (4.6 oz) can, Dist by: Bayer Healthcare LLC, Whippany, NJ 079
Hazard: cGMP Deviations: manufactured at the same facility where other lots were found to be contaminated with benzene.
November 24, 2021DrugsFDA
Bayer Healthcare Pharmaceuticals Inc. recalls Tinactin (Tolnaftate 1%) LIQUID SPRAY NET WT150g (5.3 OZ) can, labeled as (a) Product of Finland 20006101, (b) Product o
Hazard: cGMP Deviations: manufactured at the same facility where other lots were found to be contaminated with benzene.
November 24, 2021DrugsFDA
Bayer Healthcare Pharmaceuticals Inc. recalls Tinactin (Tolnaftate 1%) DEODORANT POWDER SPRAY NET WT 133g (4.6 OZ) can, labeled as (a) UPC 3 11017-410-00 4, NDC 11523
Hazard: cGMP Deviations: manufactured at the same facility where other lots were found to be contaminated with benzene.
November 24, 2021DrugsFDA
Bayer Healthcare Pharmaceuticals Inc. recalls Lotrimin AF (Miconazole nitrate 2%) Liquid Spray NET WT 133g (4.6 oz) can, Packaged as (a) single pack, UPC 0 41100 407
Hazard: cGMP Deviations: manufactured at the same facility where other lots were found to be contaminated with benzene.
November 24, 2021DrugsFDA
Bayer Healthcare Pharmaceuticals Inc. recalls LOTRIMIN AF (Tolnaftate 1%) DAILY PREVENTION deodorant powder spray, NET WT 160g (5.6 OZ) can, packaged as (a) single pa
Hazard: cGMP Deviations: manufactured at the same facility where other lots were found to be contaminated with benzene.
November 24, 2021DrugsFDA
Bayer Healthcare Pharmaceuticals Inc. recalls LOTRIMIN AF (Tolnaftate 1%) DAILY PREVENTION deodorant powder spray NET WT 133g (4.6 OZ) can, Dist by: Bayer Healthcare
Hazard: cGMP Deviations: manufactured at the same facility where other lots were found to be contaminated with benzene.
November 24, 2021DrugsFDA
Bayer Healthcare Pharmaceuticals Inc. recalls LOTRIMIN AF (Miconazole nitrate 2%) Powder Spray NET WT 133g (4.6 OZ) can, packaged as (a) a single pack NDC 11523-0544-
Hazard: cGMP Deviations: manufactured at the same facility where other lots were found to be contaminated with benzene.
November 24, 2021DrugsFDA
Bayer Healthcare Pharmaceuticals Inc. recalls LOTRIMIN AF (Miconazole nitrate 2%) Jock Itch Powder Spray NET WT 133g (4.6 OZ) can, Dist by: Bayer Healthcare LLC, Whip
Hazard: cGMP Deviations: manufactured at the same facility where other lots were found to be contaminated with benzene.
November 24, 2021DrugsFDA
Bayer Healthcare Pharmaceuticals Inc. recalls LOTRIMIN AF (Miconazole nitrate 2%) Deodorant Powder Spray NET WT 133g (4.6 OZ) can, Dist by: Bayer Healthcare LLC, Whip
Hazard: cGMP Deviations: manufactured at the same facility where other lots were found to be contaminated with benzene.
November 24, 2021DrugsFDA
Teva Pharmaceuticals USA recalls Clonidine Transdermal System, USP 0.1 mg/day, 4 patches per carton, Rx only, Manufactured by: Actavis Laboratories, UT I
Hazard: Failed Impurities/Degradation Specifications
November 24, 2021DrugsFDA
Amneal Pharmaceuticals of New York, LLC recalls Flocinolone Acetonide 0.01% Topical Oil, Scalp Oil, Rx, packaged in 4 oz. bottle, Distributed by: Amneal Pharmaceuticals
Hazard: Subpotent Drug: Out-of-specification assay result was obtained for Fluocinolone Acetonide.
November 24, 2021DrugsFDA
Amneal Pharmaceuticals of New York, LLC recalls Flocinolone Acetonide 0.01% Topical Oil, Body Oil, Rx, packaged in 4 oz. bottle, Distributed by: Amneal Pharmaceuticals
Hazard: Subpotent Drug: Out-of-specification assay result was obtained for Fluocinolone Acetonide.
November 24, 2021DrugsFDA
Teva Pharmaceuticals USA recalls Cartia XT (Diltiazem Hydrochloride Extended-Release Capsules, USP) 120 mg, Rx Only, 90 capsules, labelled as (a) Manufac
Hazard: Labelling: Incorrect Exp. Date
November 17, 2021DrugsFDA
SUN PHARMACEUTICAL INDUSTRIES INC recalls Tadalafil Tablets, USP 20 mg, 30 count bottle, Rx Only, Manufactured for: Northstar Rx LLC Memphis, TN 38141, Manufactur
Hazard: Incorrect Product Formulation: An incorrect grade of Crospovidone was used to manufacture the product.
November 17, 2021DrugsFDA
SUN PHARMACEUTICAL INDUSTRIES INC recalls Tadalafil Tablets, USP 5 mg, 30 count bottle, Rx Only, Manufactured for: Northstar Rx LLC Memphis, TN 38141, Manufacture
Hazard: Incorrect Product Formulation: An incorrect grade of Crospovidone was used to manufacture the product.
November 17, 2021DrugsFDA
Ascend Laboratories LLC recalls Cefixime Capsules 400 mg, 50 capsules bottles, Rx Only, Manufactured by: Alken Laboratories Ltd., Mumbai - 400 013, Indi
Hazard: Failed Impurities/Degradation Specifications
November 17, 2021DrugsFDA
Golden State Medical Supply Inc. recalls Ezetimibe and Simvastatin Tablets, 10 mg/80mg, 500 tablet bottles, Rx only, Manufactured by Dr. Reddy's Laboratories LA
Hazard: Failed Excipient Specification; product manufactured using an excipient found to be OOS for conductivity
November 17, 2021DrugsFDA
Golden State Medical Supply Inc. recalls Ezetimibe and Simvastatin Tablets, 10 mg/40mg, a) 90 Tablets, b) 500 tablets, Rx only, Manufactured by Dr. Reddy's Labor
Hazard: Failed Excipient Specifications and Presence of Foreign Tablets/Capsules; product manufactured using an excipient found to be OOS for conductivity and some Ezetimibe and Simvastatin Tablets, 10 mg/10 mg were found in the bottle
November 17, 2021DrugsFDA
Vita Pharmacy, LLC dba Talon Compounding Pharmacy recalls TRI-MIX PAPAVERINE 40/PHENTOLAMINE 2/PGE-1 40 INJ INJECTABLE, Rx only, Talon Compounding Pharmacy, 2950 Thousand Oaks
Hazard: Lack of assurance of sterility
November 17, 2021DrugsFDA
Vita Pharmacy, LLC dba Talon Compounding Pharmacy recalls TRI-MIX PAPAVERINE 40/PHENTOLAMINE 2/PGE-1 10 INJ INJECTABLE, Rx only, Talon Compounding Pharmacy, 2950 Thousand Oaks
Hazard: Lack of assurance of sterility
November 17, 2021DrugsFDA
Vita Pharmacy, LLC dba Talon Compounding Pharmacy recalls TRI-MIX PAPAVERINE 30/PHENTOLAMINE 6/PGE-1 60 INJ INJECTABLE, Rx only, Talon Compounding Pharmacy, 2950 Thousand Oaks
Hazard: Lack of assurance of sterility
November 17, 2021DrugsFDA
Vita Pharmacy, LLC dba Talon Compounding Pharmacy recalls TRI-MIX PAPAVERINE 30/PHENTOLAMINE 4/PGE-1 7.5/ML INJ INJECTABLE, Rx only, Talon Compounding Pharmacy, 2950 Thousand O
Hazard: Lack of assurance of sterility