FDA Drug Recalls in 2021

1,016 recalls found

November 2021

FDA

LOTRIMIN AF (Miconazole nitrate 2%) Jock Itch Powder Spray NET WT 133g (4.6 OZ) can, Dist by: Bayer Healthcare LLC, Whippany, NJ 07981, Product of Spain, NDC 11523-4140-2. UPC 3 11017 41031 8

cGMP Deviations: manufactured at the same facility where other lots were found to be contaminated with benzene.
FDA

LOTRIMIN AF (Tolnaftate 1%) DAILY PREVENTION deodorant powder spray, NET WT 160g (5.6 OZ) can, UPC 0 41100 58720 6, NDC 11523-0010-2; Dist by: Bayer Healthcare LLC, Whippany, NJ 07981, Product of Finland, Packaged with LOTRIMIN ULTRA (butenafine hydrochloride 1%) cream, UPC 0 11017 40823 9, Dist by: Bayer Healthcare LLC, Whippany, NJ 07981, Product of Japan, ECOM PK UPC 00041100590756 NDC 11523-0010-2

cGMP Deviations: LOTRIMIN AF (Tolnaftate 1%) manufactured at the same facility where other lots were found to be contaminated with benzene.
FDA

Flocinolone Acetonide 0.01% Topical Oil, Body Oil, Rx, packaged in 4 oz. bottle, Distributed by: Amneal Pharmaceuticals Bridgewater, NJ 08807, NDC 65162-704-86

Subpotent Drug: Out-of-specification assay result was obtained for Fluocinolone Acetonide.
FDA

Tinactin (Tolnaftate 1%) LIQUID SPRAY NET WT150g (5.3 OZ) can, labeled as (a) Product of Finland 20006101, (b) Product of Ireland 87022897, (c) Product of Ireland 87022897, with an instant redeemable coupon (IRC) tag attached to the can; Dist by: Bayer Healthcare LLC, Whippany, NJ 07981, UPC 3 11017 41005 9, NDC 11523-0165-3 Tinactin (Tolnaftate 1%) LIQUID SPRAY NET WT150g (5.3 OZ) can, Labeled as (a) Product of Finland 20006101, (b) Product of Ireland 87022897, Dist by: Bayer Healthcar

cGMP Deviations: manufactured at the same facility where other lots were found to be contaminated with benzene.
FDA

Tinactin (Tolnaftate 1%) JOCK ITCH POWDER SPRAY NET WT133g (4.6 oz) can, Dist by: Bayer Healthcare LLC, Whippany, NJ 07981, Product of Finland 20066104 UPC 3 11017 41007 3, NDC 11523-0072-5

Chemical Contamination: presence of benzene
FDA

Cartia XT (Diltiazem Hydrochloride Extended-Release Capsules, USP) 120 mg, Rx Only, 90 capsules, labelled as (a) Manufactured By: Teva Pharmaceuticals USA, Inc., Parsippany, NJ 07054; (b) Manufactured By: Actavis Laboratories FL. Inc, Fort Lauderdale FL. 33314 USA, Distributed by Avista Pharma Inc. Parsippany, NJ 07054 USA. NDC 62037-597-90

Labelling: Incorrect Exp. Date
FDA

LOTRIMIN AF (Miconazole nitrate 2%) Powder Spray NET WT 133g (4.6 OZ) can, packaged as (a) a single pack NDC 11523-0544-2 UPC 3 11017 41025 7; (b) 3 pack, NDC 11523-0544-2, UPC 0 41100 58594 3; Dist by: Bayer Healthcare LLC, Whippany, NJ 07981, Product of Spain, ,

cGMP Deviations: manufactured at the same facility where other lots were found to be contaminated with benzene.
FDA

Lotrimin AF (Miconazole nitrate 2%) Liquid Spray NET WT 133g (4.6 oz) can, Packaged as (a) single pack, UPC 0 41100 40788 7, NDC 11523-4327-1; (b) 3-pack UPC 0 41100 58593 6; Dist by: Bayer Healthcare LLC, Whippany, NJ 07981, Product of Spain

cGMP Deviations: manufactured at the same facility where other lots were found to be contaminated with benzene.
FDA

Tinactin (Tolnaftate 1%) POWDER SPRAY NET WT 133g (4.6 oz) can, Labeled as (a) Product of Ireland 86940418, (b)Product of Finland 20006106, (c) Product of Ireland with Instant redeemable coupon ( IRC); Dist by: Bayer Healthcare LLC, Whippany, NJ 07981, Product of Finland, UPC 3 11017 41009 7, NDC 11523-0777-2.

cGMP Deviations: manufactured at the same facility where other lots were found to be contaminated with benzene.
FDA

Clonidine Transdermal System, USP 0.1 mg/day, 4 patches per carton, Rx only, Manufactured by: Actavis Laboratories, UT Inc., Salt Lake City, UT, Distributed by: Actavis Pharma, Inc., Parsippany, NJ NDC 0591-3508-04

Failed Impurities/Degradation Specifications
FDA

Tinactin (Tolnaftate 1%) JOCK ITCH POWDER SPRAY NET WT133g (4.6 oz) can, Dist by: Bayer Healthcare LLC, Whippany, NJ 07981, Product of Ireland 86951967, UPC 3 11017 41007 3, NDC 11523-0072-5

cGMP Deviations: manufactured at the same facility where other lots were found to be contaminated with benzene.
FDA

LOTRIMIN AF, (Miconazole nitrate 2%), Powder Spray, NET WT 133g (4.6 OZ) can, Dist by: Bayer Healthcare LLC, Whippany, NJ 07981, Product of Spain, NDC 11523-0544-2 UPC 3 11017 41025 7

Chemical Contamination: presence of benzene
FDA

Flocinolone Acetonide 0.01% Topical Oil, Scalp Oil, Rx, packaged in 4 oz. bottle, Distributed by: Amneal Pharmaceuticals Bridgewater, NJ 08807, NDC 65162-703-86

Subpotent Drug: Out-of-specification assay result was obtained for Fluocinolone Acetonide.
FDA

B COMPLEX INJ CMP-NO B12, NO LIDOCAINE INJECTABLE, Rx only, Talon Compounding Pharmacy, 2950 Thousand Oaks Drive Ste 25, San Antonio, Texas 78247

Lack of assurance of sterility
FDA

ALPROSTADIL 40MCG/ML INJ 40MCG/ML INJECTABLE, Rx only, Talon Compounding Pharmacy, 2950 Thousand Oaks Drive Ste 25, San Antonio, Texas 78247

Lack of assurance of sterility
FDA

TRI-TEST 200 (CY50%-EN37.5%-PR12.5%) INJ #1 200MG/ML INJECTABLE, Rx only, Talon Compounding Pharmacy, 2950 Thousand Oaks Drive Ste 25, San Antonio, Texas 78247

Lack of assurance of sterility
FDA

TEST CYPIONATE 200MG/ANASTROZOLE 1MG/DUTASTERIDE 0.5MG/ML IN OIL INJECTABLE, Rx only, Talon Compounding Pharmacy, 2950 Thousand Oaks Drive Ste 25, San Antonio, Texas 78247

Lack of assurance of sterility
FDA

ULTRA-TEST (CYP 80%/PROP 20%) 200MG/ML INJ #1 200MG/ML INJECTABLE, Rx only, Talon Compounding Pharmacy, 2950 Thousand Oaks Drive Ste 25, San Antonio, Texas 78247

Lack of assurance of sterility
FDA

TESTOSTERONE CYPIONATE 200MG/ML INJ #2 IN SESAME OIL INJECTABLE, Rx only, Talon Compounding Pharmacy, 2950 Thousand Oaks Drive Ste 25, San Antonio, Texas 78247

Lack of assurance of sterility
FDA

TEST CYPIONATE 200MG/ANASTROZOLE 0.5MG/DUTASTERIDE 0.5MG/ML IN OIL INJECTABLE, Rx only, Talon Compounding Pharmacy, 2950 Thousand Oaks Drive Ste 25, San Antonio, Texas 78247

Lack of assurance of sterility
FDA

IC B COMPLEX INJ INJECTABLE, Rx only, Talon Compounding Pharmacy, 2950 Thousand Oaks Drive Ste 25, San Antonio, Texas 78247

Lack of assurance of sterility
FDA

TRI-MIX PAPAVERINE 30/PHENTOLAMINE 0.25/PGE-1 6 INJ INJECTABLE, Rx only, Talon Compounding Pharmacy, 2950 Thousand Oaks Drive Ste 25, San Antonio, Texas 78247

Lack of assurance of sterility
FDA

TRI-MIX PAPAVERINE 18/PHENTOL 0.6/PGE-1 5.88/ML INJ INJECTABLE, Rx only, Talon Compounding Pharmacy, 2950 Thousand Oaks Drive Ste 25, San Antonio, Texas 78247

Lack of assurance of sterility
FDA

SERMORELIN ACETATE 6MG/IPAMORELIN 6MG - LYOPHILIZED 6MG/6MG VIAL, Rx only, Talon Compounding Pharmacy, 2950 Thousand Oaks Drive Ste 25, San Antonio, Texas 78247

Lack of assurance of sterility
FDA

CJC-1295 4MG/IPAMORELIN 4MG VIAL 4MG/4MG INJECTABLE, Rx only, Talon Compounding Pharmacy, 2950 Thousand Oaks Drive Ste 25, San Antonio, Texas 78247

Lack of assurance of sterility
FDA

TRI-MIX PAPAVERINE 30/PHENTOLAMINE 4/PGE-1 7.5/ML INJ INJECTABLE, Rx only, Talon Compounding Pharmacy, 2950 Thousand Oaks Drive Ste 25, San Antonio, Texas 78247

Lack of assurance of sterility
FDA

TRI-MIX PAPAVERINE 40/PHENTOLAMINE 2/PGE-1 40 INJ INJECTABLE, Rx only, Talon Compounding Pharmacy, 2950 Thousand Oaks Drive Ste 25, San Antonio, Texas 78247

Lack of assurance of sterility
FDA

MIC B12 25/50/50/0.5MG/ML L-CARNITINE 250MG/ML INJECTABLE, Rx only, Talon Compounding Pharmacy, 2950 Thousand Oaks Drive Ste 25, San Antonio, Texas 78247

Lack of assurance of sterility
FDA

ALPROSTADIL 22MCG/ML 22MCG/ML INJECTABLE, Rx only, Talon Compounding Pharmacy, 2950 Thousand Oaks Drive Ste 25, San Antonio, Texas 78247

Lack of assurance of sterility
FDA

TRI-MIX PAPAVERINE 30/PHENTOLAMINE 0.5/PGE-1 20 INJ INJECTABLE, Rx only, Talon Compounding Pharmacy, 2950 Thousand Oaks Drive Ste 25, San Antonio, Texas 78247

Lack of assurance of sterility
FDA

TRI-MIX PAPAVERINE 30/PHENTOLAMINE 1/PGE-1 12 INJ INJECTABLE, Rx only, Talon Compounding Pharmacy, 2950 Thousand Oaks Drive Ste 25, San Antonio, Texas 78247

Lack of assurance of sterility
FDA

TRI-MIX PAPAVERINE 18/PHENTOL 0.6/PGE-1 6/ML INJ INJECTABLE, Rx only, Talon Compounding Pharmacy, 2950 Thousand Oaks Drive Ste 25, San Antonio, Texas 78247

Lack of assurance of sterility
FDA

TESTOSTERONE CYPIONATE 200MG/ML INJ #1 IN ETHYL OLEATE INJECTABLE, Rx only, Talon Compounding Pharmacy, 2950 Thousand Oaks Drive Ste 25, San Antonio, Texas 78247

Lack of assurance of sterility
FDA

MIC B12 25/50/50/1+B6 100 MG/ML INJ INJECTABLE, Rx only, Talon Compounding Pharmacy, 2950 Thousand Oaks Drive Ste 25, San Antonio, Texas 78247

Lack of assurance of sterility
FDA

TRI-MIX PAPAVERINE 30/PHENTOLAMINE 3/PGE-1 100 INJ INJECTABLE, Rx only, Talon Compounding Pharmacy, 2950 Thousand Oaks Drive Ste 25, San Antonio, Texas 78247

Lack of assurance of sterility
FDA

ESTRADIOL VALERATE 50MG/ML IN ETHYL OLEATE INJ INJECTABLE, Rx only, Talon Compounding Pharmacy, 2950 Thousand Oaks Drive Ste 25, San Antonio, Texas 78247

Lack of assurance of sterility
FDA

MIC B COMPLEX W CHROMIUM/ METHYLCOB (BOYDEN) INJ INJECTABLE, Rx only, Talon Compounding Pharmacy, 2950 Thousand Oaks Drive Ste 25, San Antonio, Texas 78247

Lack of assurance of sterility
FDA

TESTOSTERONE CYPIONATE 200MG/ANASTROZOLE 0.25MG/ML IN OIL INJECTABLE, Rx only, Talon Compounding Pharmacy, 2950 Thousand Oaks Drive Ste 25, San Antonio, Texas 78247

Lack of assurance of sterility
FDA

Estradiol Valerate 20 mg/mL in Ethyl Oleate Inj. 20 mg/mL Injection in vials, Rx only, Talon Compounding Pharmacy, 2950 Thousand Oaks Drive Ste 25, San Antonio, Texas 78247

Lack of assurance of sterility
FDA

QUAD-MIX PAPAV 30/PHENTOL 1/PGE-1 10/ATROPINE 0.15 INJ INJECTABLE, Rx only, Talon Compounding Pharmacy, 2950 Thousand Oaks Drive Ste 25, San Antonio, Texas 78247

Lack of assurance of sterility
FDA

TRI-MIX PAPAVERINE 30/PHENTOLAMINE 1/PGE-1 5 INJ INJECTABLE, Rx only, Talon Compounding Pharmacy, 2950 Thousand Oaks Drive Ste 25, San Antonio, Texas 78247

Lack of assurance of sterility
FDA

TESTOSTERONE CYPIONATE 200MG/ANASTROZOLE 1.5MG/ML IN OIL INJECTABLE, Rx only, Talon Compounding Pharmacy, 2950 Thousand Oaks Drive Ste 25, San Antonio, Texas 78247

Lack of assurance of sterility
FDA

ESTRADIOL VALERATE 10MG/ML IN ETHYL OLEATE 10MG/ML INJECTABLE, Rx only, Talon Compounding Pharmacy, 2950 Thousand Oaks Drive Ste 25, San Antonio, Texas 78247

Lack of assurance of sterility
FDA

TRI-MIX PAPAVERINE 30/PHENTOLAMINE 1.5/PGE-1 50 INJ **ST 1** INJECTABLE, Rx only, Talon Compounding Pharmacy, 2950 Thousand Oaks Drive Ste 25, San Antonio, Texas 78247

Lack of assurance of sterility
FDA

HYDROXOCOBALAMIN 5,000MCG/ML INJ 5,000MCG/ML INJECTABLE, Rx only, Talon Compounding Pharmacy, 2950 Thousand Oaks Drive Ste 25, San Antonio, Texas 78247

Lack of assurance of sterility
FDA

BLUE TREE LIPO EXTREME (/W METHYLCOBALAMIN) INJECTION INJECTABLE, Rx only, Talon Compounding Pharmacy, 2950 Thousand Oaks Drive Ste 25, San Antonio, Texas 78247

Lack of assurance of sterility
FDA

TRI-MIX PAPAVERINE 30/PHENTOLAMINE 1/PGE-1 25 INJ**T 106** INJECTABLE, Rx only, Talon Compounding Pharmacy, 2950 Thousand Oaks Drive Ste 25, San Antonio, Texas 78247

Lack of assurance of sterility
FDA

TEST CYPIONATE 200MG/ANASTROZOLE 0.5MG/DUTASTERIDE 1MG/ML IN OIL INJECTABLE, Rx only, Talon Compounding Pharmacy, 2950 Thousand Oaks Drive Ste 25, San Antonio, Texas 78247

Lack of assurance of sterility
FDA

Ezetimibe and Simvastatin Tablets, 10 mg/40mg, a) 90 Tablets, b) 500 tablets, Rx only, Manufactured by Dr. Reddy's Laboratories LA LLC Shreveport, LA 71106 USA, Packaged by GSMS, Incorporated Camarillo, CA 93012 USA; NDC: a) 51407-192-90, b) 51407-192-05

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
FDA

TRI-MIX PAPAVERINE 30/PHENTOLAMINE 1/PGE-1 40 INJ INJECTABLE, Rx only, Talon Compounding Pharmacy, 2950 Thousand Oaks Drive Ste 25, San Antonio, Texas 78247

Lack of assurance of sterility