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FDA Drug Recalls

18043 recall notices on file. Class I recalls involve a reasonable probability of serious adverse health consequences or death.

ProductFirmClassificationStatusReport date
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, , Bayer Healthcare Pharmaceuticals Inc. Class II Terminated 20211124
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 Bayer Healthcare Pharmaceuticals Inc. Class II Terminated 20211124
LOTRIMIN AF (Miconazole nitrate 2%) Deodorant Powder Spray NET WT 133g (4.6 OZ) can, Dist by: Bayer Healthcare LLC, Whippany, NJ 07981, Product of Spain, NDC 11523-1272-2 UPC 3 11017 41023 3 Bayer Healthcare Pharmaceuticals Inc. Class II Terminated 20211124
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 Teva Pharmaceuticals USA Class III Terminated 20211124
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 Amneal Pharmaceuticals of New York, LLC Class II Terminated 20211124
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 Amneal Pharmaceuticals of New York, LLC Class II Terminated 20211124
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 Teva Pharmaceuticals USA Class II Terminated 20211124
Tadalafil Tablets, USP 20 mg, 30 count bottle, Rx Only, Manufactured for: Northstar Rx LLC Memphis, TN 38141, Manufactured by: Sun Pharmaceutical Industries Limited, India, NDC # 16714-077-01 SUN PHARMACEUTICAL INDUSTRIES INC Class II Terminated 20211117
Tadalafil Tablets, USP 5 mg, 30 count bottle, Rx Only, Manufactured for: Northstar Rx LLC Memphis, TN 38141, Manufactured by: Sun Pharmaceutical Industries Limited, India, NDC # 16714-075-01 SUN PHARMACEUTICAL INDUSTRIES INC Class II Terminated 20211117
Cefixime Capsules 400 mg, 50 capsules bottles, Rx Only, Manufactured by: Alken Laboratories Ltd., Mumbai - 400 013, India, Distributed by: Ascend Laboratories LLC, Parsippany, NJ, 07054 NDC 67877-584-50 Ascend Laboratories LLC Class II Terminated 20211117
Ezetimibe and Simvastatin Tablets, 10 mg/80mg, 500 tablet bottles, Rx only, Manufactured by Dr. Reddy's Laboratories LA LLC Shreveport, LA 71106 USA, Packaged by GSMS, Incorporated Camarillo, CA 93012 USA; NDC 51407-193-05 Golden State Medical Supply Inc. Class II Terminated 20211117
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 Golden State Medical Supply Inc. Class II Terminated 20211117
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 Vita Pharmacy, LLC dba Talon Compounding Pharmacy Class II Terminated 20211117
TRI-MIX PAPAVERINE 40/PHENTOLAMINE 2/PGE-1 10 INJ INJECTABLE, Rx only, Talon Compounding Pharmacy, 2950 Thousand Oaks Drive Ste 25, San Antonio, Texas 78247 Vita Pharmacy, LLC dba Talon Compounding Pharmacy Class II Terminated 20211117
TRI-MIX PAPAVERINE 30/PHENTOLAMINE 6/PGE-1 60 INJ INJECTABLE, Rx only, Talon Compounding Pharmacy, 2950 Thousand Oaks Drive Ste 25, San Antonio, Texas 78247 Vita Pharmacy, LLC dba Talon Compounding Pharmacy Class II Terminated 20211117
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 Vita Pharmacy, LLC dba Talon Compounding Pharmacy Class II Terminated 20211117
TRI-MIX PAPAVERINE 30/PHENTOLAMINE 4/PGE-1 60 INJ INJECTABLE, Rx only, Talon Compounding Pharmacy, 2950 Thousand Oaks Drive Ste 25, San Antonio, Texas 78247 Vita Pharmacy, LLC dba Talon Compounding Pharmacy Class II Terminated 20211117
TRI-MIX PAPAVERINE 30/PHENTOLAMINE 4/PGE-1 5 INJ INJECTABLE, Rx only, Talon Compounding Pharmacy, 2950 Thousand Oaks Drive Ste 25, San Antonio, Texas 78247 Vita Pharmacy, LLC dba Talon Compounding Pharmacy Class II Terminated 20211117
TRI-MIX PAPAVERINE 30/PHENTOLAMINE 4/PGE-1 20 INJ INJECTABLE, Rx only, Talon Compounding Pharmacy, 2950 Thousand Oaks Drive Ste 25, San Antonio, Texas 78247 Vita Pharmacy, LLC dba Talon Compounding Pharmacy Class II Terminated 20211117
TRI-MIX PAPAVERINE 30/PHENTOLAMINE 3/PGE-1 40 INJ INJECTABLE, Rx only, Talon Compounding Pharmacy, 2950 Thousand Oaks Drive Ste 25, San Antonio, Texas 78247 Vita Pharmacy, LLC dba Talon Compounding Pharmacy Class II Terminated 20211117
TRI-MIX PAPAVERINE 30/PHENTOLAMINE 3/PGE-1 40 INJ INJECTABLE, Rx only, Talon Compounding Pharmacy, 2950 Thousand Oaks Drive Ste 25, San Antonio, Texas 78247 Vita Pharmacy, LLC dba Talon Compounding Pharmacy Class II Terminated 20211117
TRI-MIX PAPAVERINE 30/PHENTOLAMINE 3/PGE-1 30 INJ INJECTABLE, Rx only, Talon Compounding Pharmacy, 2950 Thousand Oaks Drive Ste 25, San Antonio, Texas 78247 Vita Pharmacy, LLC dba Talon Compounding Pharmacy Class II Terminated 20211117
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 Vita Pharmacy, LLC dba Talon Compounding Pharmacy Class II Terminated 20211117
TRI-MIX PAPAVERINE 30/PHENTOLAMINE 2/PGE-1 60 INJ INJECTABLE, Rx only, Talon Compounding Pharmacy, 2950 Thousand Oaks Drive Ste 25, San Antonio, Texas 78247 Vita Pharmacy, LLC dba Talon Compounding Pharmacy Class II Terminated 20211117
TRI-MIX PAPAVERINE 30/PHENTOLAMINE 2/PGE-1 50 INJ INJECTABLE, Rx only, Talon Compounding Pharmacy, 2950 Thousand Oaks Drive Ste 25, San Antonio, Texas 78247 Vita Pharmacy, LLC dba Talon Compounding Pharmacy Class II Terminated 20211117
TRI-MIX PAPAVERINE 30/PHENTOLAMINE 2/PGE-1 40 INJ INJECTABLE, Rx only, Talon Compounding Pharmacy, 2950 Thousand Oaks Drive Ste 25, San Antonio, Texas 78247 Vita Pharmacy, LLC dba Talon Compounding Pharmacy Class II Terminated 20211117
TRI-MIX PAPAVERINE 30/PHENTOLAMINE 2/PGE-1 30 INJ INJECTABLE, Rx only, Talon Compounding Pharmacy, 2950 Thousand Oaks Drive Ste 25, San Antonio, Texas 78247 Vita Pharmacy, LLC dba Talon Compounding Pharmacy Class II Terminated 20211117
TRI-MIX PAPAVERINE 30/PHENTOLAMINE 2/PGE-1 20 INJ **T 104** INJECTABLE, Rx only, Talon Compounding Pharmacy, 2950 Thousand Oaks Drive Ste 25, San Antonio, Texas 78247 Vita Pharmacy, LLC dba Talon Compounding Pharmacy Class II Terminated 20211117
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 Vita Pharmacy, LLC dba Talon Compounding Pharmacy Class II Terminated 20211117
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 Vita Pharmacy, LLC dba Talon Compounding Pharmacy Class II Terminated 20211117
TRI-MIX PAPAVERINE 30/PHENTOLAMINE 1/PGE-1 30 INJ INJECTABLE, Rx only, Talon Compounding Pharmacy, 2950 Thousand Oaks Drive Ste 25, San Antonio, Texas 78247 Vita Pharmacy, LLC dba Talon Compounding Pharmacy Class II Terminated 20211117
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 Vita Pharmacy, LLC dba Talon Compounding Pharmacy Class II Terminated 20211117
TRI-MIX PAPAVERINE 30/PHENTOLAMINE 1/PGE-1 20 INJ INJECTABLE, Rx only, Talon Compounding Pharmacy, 2950 Thousand Oaks Drive Ste 25, San Antonio, Texas 78247 Vita Pharmacy, LLC dba Talon Compounding Pharmacy Class II Terminated 20211117
TRI-MIX PAPAVERINE 30/PHENTOLAMINE 1/PGE-1 2.5 INJ INJECTABLE, Rx only, Talon Compounding Pharmacy, 2950 Thousand Oaks Drive Ste 25, San Antonio, Texas 78247 Vita Pharmacy, LLC dba Talon Compounding Pharmacy Class II Terminated 20211117
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 Vita Pharmacy, LLC dba Talon Compounding Pharmacy Class II Terminated 20211117
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 Vita Pharmacy, LLC dba Talon Compounding Pharmacy Class II Terminated 20211117
TRI-MIX PAPAVERINE 30/PHENTOLAMINE 0.5/PGE-1 40 /ML INJECTABLE, Rx only, Talon Compounding Pharmacy, 2950 Thousand Oaks Drive Ste 25, San Antonio, Texas 78247 Vita Pharmacy, LLC dba Talon Compounding Pharmacy Class II Terminated 20211117
TRI-MIX PAPAVERINE 30/PHENTOLAMINE 0.5/PGE-1 30 INJ INJECTABLE, Rx only, Talon Compounding Pharmacy, 2950 Thousand Oaks Drive Ste 25, San Antonio, Texas 78247 Vita Pharmacy, LLC dba Talon Compounding Pharmacy Class II Terminated 20211117
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 Vita Pharmacy, LLC dba Talon Compounding Pharmacy Class II Terminated 20211117
TRI-MIX PAPAVERINE 30/PHENTOLAMINE 0.5/PGE-1 10 INJ INJECTABLE, Rx only, Talon Compounding Pharmacy, 2950 Thousand Oaks Drive Ste 25, San Antonio, Texas 78247 Vita Pharmacy, LLC dba Talon Compounding Pharmacy Class II Terminated 20211117
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 Vita Pharmacy, LLC dba Talon Compounding Pharmacy Class II Terminated 20211117
TRI-MIX PAPAVERINE 26/PHENTOLAMINE 3/PGE-1 60/ML INJ INJECTABLE, Rx only, Talon Compounding Pharmacy, 2950 Thousand Oaks Drive Ste 25, San Antonio, Texas 78247 Vita Pharmacy, LLC dba Talon Compounding Pharmacy Class II Terminated 20211117
TRI-MIX PAPAVERINE 25MG/PHENTOLAMINE 1MG/PGE1 25MCG/ML INJ INJECTABLE, Rx only, Talon Compounding Pharmacy, 2950 Thousand Oaks Drive Ste 25, San Antonio, Texas 78247 Vita Pharmacy, LLC dba Talon Compounding Pharmacy Class II Terminated 20211117
TRI-MIX PAPAVERINE 25/PHENTOLAMINE 3/PGE-1 80 INJ INJECTABLE, Rx only, Talon Compounding Pharmacy, 2950 Thousand Oaks Drive Ste 25, San Antonio, Texas 78247 Vita Pharmacy, LLC dba Talon Compounding Pharmacy Class II Terminated 20211117
TRI-MIX PAPAVERINE 23.3/PHENTOLAMINE 1/PGE-1 12 INJ INJECTABLE, Rx only, Talon Compounding Pharmacy, 2950 Thousand Oaks Drive Ste 25, San Antonio, Texas 78247 Vita Pharmacy, LLC dba Talon Compounding Pharmacy Class II Terminated 20211117
TRI-MIX PAPAVERINE 20/PHENTOLAMINE 1/PGE-1 20 INJ INJECTABLE, Rx only, Talon Compounding Pharmacy, 2950 Thousand Oaks Drive Ste 25, San Antonio, Texas 78247 Vita Pharmacy, LLC dba Talon Compounding Pharmacy Class II Terminated 20211117
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 Vita Pharmacy, LLC dba Talon Compounding Pharmacy Class II Terminated 20211117
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 Vita Pharmacy, LLC dba Talon Compounding Pharmacy Class II Terminated 20211117
TRI-MIX PAPAVERINE 17.65/PHENTOLAMINE 0.59/PGE-1 5.9 INJ **T 101** INJECTABLE, Rx only, Talon Compounding Pharmacy, 2950 Thousand Oaks Drive Ste 25, San Antonio, Texas 78247 Vita Pharmacy, LLC dba Talon Compounding Pharmacy Class II Terminated 20211117
TRI-MIX PAPAVERINE 15/PHENTOLAMINE 2/PGE-1 20 INJ INJECTABLE, Rx only, Talon Compounding Pharmacy, 2950 Thousand Oaks Drive Ste 25, San Antonio, Texas 78247 Vita Pharmacy, LLC dba Talon Compounding Pharmacy Class II Terminated 20211117