Drug Recall Enforcement Reports

What are the Drug Enforcement Reports?

All drug recalls are monitored by the Food and Drug Administration (FDA) and are included in the Enforcement Report once they are properly classified. The FDA will determine if a firm's removal or correction actions of a marked product meet the requirements to be considered a "recall". The FDA will also determine the public hazard assessment and a recall classification will be published in the Enforcement Report.

The Drug Enforcement Reports included in this listing was last updated on 11-29-2021 and include a total of 13308 recall reports.

Recall Number Initiation Date Product Description Recall Reason Recall Firm / Quantity Recall Classification Status
D-0186-202210-12-2021TRI-MIX PAPAVERINE 15/PHENTOLAMINE 0.25/PGE-1 6 INJ INJECTABLE, Rx only, Talon Compounding Pharmacy, 2950 Thousand Oaks Drive Ste 25, San Antonio, Texas 78247Lack of assurance of sterilityVita Pharmacy, LLC dba Talon Compounding Pharmacy / 24 vialsClass IIOngoing
D-0176-202210-12-2021TESTOSTERONE CYPIONATE 200MG/ANASTROZOLE 1.75MG/ML IN OIL INJECTABLE, Rx only, Talon Compounding Pharmacy, 2950 Thousand Oaks Drive Ste 25, San Antonio, Texas 78247Lack of assurance of sterilityVita Pharmacy, LLC dba Talon Compounding Pharmacy / 2 vialsClass IIOngoing
D-0203-202210-12-2021TRI-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 78247Lack of assurance of sterilityVita Pharmacy, LLC dba Talon Compounding Pharmacy / 3 vialsClass IIOngoing
D-0138-202210-12-2021QUAD-MIX PAPAV 30/PHENTOL 2/PGE-1 20/ATROPINE 0.2 INJ *C5* INJECTABLE, Rx only, Talon Compounding Pharmacy, 2950 Thousand Oaks Drive Ste 25, San Antonio, Texas 78247Lack of assurance of sterilityVita Pharmacy, LLC dba Talon Compounding Pharmacy / 3 vialsClass IIOngoing
D-0133-202210-12-2021MIC 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 78247Lack of assurance of sterilityVita Pharmacy, LLC dba Talon Compounding Pharmacy / 1 vialClass IIOngoing
D-0183-202210-12-2021TESTOSTERONE CYPIONATE 30MG/ML #1 IN ETHYL OLEATE INJECTABLE, Rx only, Talon Compounding Pharmacy, 2950 Thousand Oaks Drive Ste 25, San Antonio, Texas 78247Lack of assurance of sterilityVita Pharmacy, LLC dba Talon Compounding Pharmacy / 1 vialClass IIOngoing
D-0156-202210-12-2021TEST CYPIONATE 200MG/ANASTROZOLE 0.75MG/DUTASTERIDE 1MG/ML IN OIL INJECTABLE, Rx only, Talon Compounding Pharmacy, 2950 Thousand Oaks Drive Ste 25, San Antonio, Texas 78247Lack of assurance of sterilityVita Pharmacy, LLC dba Talon Compounding Pharmacy / 2 vialsClass IIOngoing
D-0149-202210-12-2021VITAMIN D3 100,000 IU/ML INJECTABLE 100,000IU/ML, Rx only, Talon Compounding Pharmacy, 2950 Thousand Oaks Drive Ste 25, San Antonio, Texas 78247Lack of assurance of sterilityVita Pharmacy, LLC dba Talon Compounding Pharmacy / 23 vialsClass IIOngoing
D-0124-202210-12-2021MEDROXYPROGESTERONE ACET 150MG/ML SUSP (PF) 150MG/ML SUSPENSION, Rx only, Talon Compounding Pharmacy, 2950 Thousand Oaks Drive Ste 25, San Antonio, Texas 78247Lack of assurance of sterilityVita Pharmacy, LLC dba Talon Compounding Pharmacy / 696 vialsClass IIOngoing
D-0221-202210-12-2021TRI-MIX PAPAVERINE 30/PHENTOLAMINE 4/PGE-1 5 INJ INJECTABLE, Rx only, Talon Compounding Pharmacy, 2950 Thousand Oaks Drive Ste 25, San Antonio, Texas 78247Lack of assurance of sterilityVita Pharmacy, LLC dba Talon Compounding Pharmacy / 1 vialClass IIOngoing
D-0113-202210-12-2021ESTRADIOL VALERATE 50MG/ML IN ETHYL OLEATE INJ INJECTABLE, Rx only, Talon Compounding Pharmacy, 2950 Thousand Oaks Drive Ste 25, San Antonio, Texas 78247Lack of assurance of sterilityVita Pharmacy, LLC dba Talon Compounding Pharmacy / 15 vialsClass IIOngoing
D-0172-202210-12-2021TESTOSTERONE CYPIONATE 200MG/ANASTROZOLE 0.5MG/ML INJ #2 IN SESAME OIL INJECTABLE, Rx only, Talon Compounding Pharmacy, 2950 Thousand Oaks Drive Ste 25, San Antonio, Texas 78247Lack of assurance of sterilityVita Pharmacy, LLC dba Talon Compounding Pharmacy / 9 vialsClass IIOngoing
D-0146-202210-12-2021TRIMTROPIC - MIC B COMPLEX/CHROM/CARN 20MG/40MG/50MG/5MG/33MG/2MG/1MG/25MCG/25MG INJECTABLE, Rx only, Talon Compounding Pharmacy, 2950 Thousand Oaks Drive Ste 25, San Antonio, Texas 78247Lack of assurance of sterilityVita Pharmacy, LLC dba Talon Compounding Pharmacy / 1 vialClass IIOngoing
D-0114-202210-12-2021ESTRADIOL VALERATE 50MG/ML INJ #2 INJECTABLE, Rx only, Talon Compounding Pharmacy, 2950 Thousand Oaks Drive Ste 25, San Antonio, Texas 78247Lack of assurance of sterilityVita Pharmacy, LLC dba Talon Compounding Pharmacy / 1 vialsClass IIOngoing
D-0140-202210-12-2021QUAD-MIX PAPAV 30/PHENTOL 2/PGE-1 30/ATROPINE 0.2 INJ INJECTABLE, Rx only, Talon Compounding Pharmacy, 2950 Thousand Oaks Drive Ste 25, San Antonio, Texas 78247Lack of assurance of sterilityVita Pharmacy, LLC dba Talon Compounding Pharmacy / 3 vialsClass IIOngoing
D-0103-202210-12-2021ALPROSTADIL 32MCG/ML 32MCG/ML INJECTABLE, Rx only, Talon Compounding Pharmacy, 2950 Thousand Oaks Drive Ste 25, San Antonio, Texas 78247Lack of assurance of sterilityVita Pharmacy, LLC dba Talon Compounding Pharmacy / 1 vialClass IIOngoing
D-0182-202210-12-2021TESTOSTERONE CYPIONATE 25MG/ML INJ #1 IN ETHYL OLEATE INJECTABLE, Rx only, Talon Compounding Pharmacy, 2950 Thousand Oaks Drive Ste 25, San Antonio, Texas 78247Lack of assurance of sterilityVita Pharmacy, LLC dba Talon Compounding Pharmacy / 16 vialsClass IIOngoing
D-0162-202210-12-2021TEST CYPIONATE 200MG/ANASTROZOLE 1MG/DUTASTERIDE 2MG/ML IN OIL INJECTABLE, Rx only, Talon Compounding Pharmacy, 2950 Thousand Oaks Drive Ste 25, San Antonio, Texas 78247Lack of assurance of sterilityVita Pharmacy, LLC dba Talon Compounding Pharmacy / 6 vialsClass IIOngoing
D-0211-202210-12-2021TRI-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 78247Lack of assurance of sterilityVita Pharmacy, LLC dba Talon Compounding Pharmacy / 22 vialsClass IIOngoing
D-0130-202210-12-2021MIC B COMPLEX W CHROMIUM/ METHYLCOB (BOYDEN) INJ INJECTABLE, Rx only, Talon Compounding Pharmacy, 2950 Thousand Oaks Drive Ste 25, San Antonio, Texas 78247Lack of assurance of sterilityVita Pharmacy, LLC dba Talon Compounding Pharmacy / 4 vialsClass IIOngoing
D-0174-202210-12-2021TESTOSTERONE CYPIONATE 200MG/ANASTROZOLE 0.7MG/ML IN OIL INJECTABLE, Rx only, Talon Compounding Pharmacy, 2950 Thousand Oaks Drive Ste 25, San Antonio, Texas 78247Lack of assurance of sterilityVita Pharmacy, LLC dba Talon Compounding Pharmacy / 2 vialsClass IIOngoing
D-0134-202210-12-2021PROGESTERONE 100MG/ML INJ #1 IN ETHYL OLEATE INJECTABLE, Rx only, Talon Compounding Pharmacy, 2950 Thousand Oaks Drive Ste 25, San Antonio, Texas 78247Lack of assurance of sterilityVita Pharmacy, LLC dba Talon Compounding Pharmacy / 1 vialClass IIOngoing
D-0178-202210-12-2021TESTOSTERONE CYPIONATE 200MG/ANASTROZOLE 1MG/ML IN OIL INJECTABLE, Rx only, Talon Compounding Pharmacy, 2950 Thousand Oaks Drive Ste 25, San Antonio, Texas 78247Lack of assurance of sterilityVita Pharmacy, LLC dba Talon Compounding Pharmacy / 334 vialsClass IIOngoing
D-0199-202210-12-2021TRI-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 78247Lack of assurance of sterilityVita Pharmacy, LLC dba Talon Compounding Pharmacy / 4 vialsClass IIOngoing
D-0204-202210-12-2021TRI-MIX PAPAVERINE 30/PHENTOLAMINE 1/PGE-1 12 INJ INJECTABLE, Rx only, Talon Compounding Pharmacy, 2950 Thousand Oaks Drive Ste 25, San Antonio, Texas 78247Lack of assurance of sterilityVita Pharmacy, LLC dba Talon Compounding Pharmacy / 13 vialsClass IIOngoing
D-0224-202210-12-2021TRI-MIX PAPAVERINE 30/PHENTOLAMINE 6/PGE-1 60 INJ INJECTABLE, Rx only, Talon Compounding Pharmacy, 2950 Thousand Oaks Drive Ste 25, San Antonio, Texas 78247Lack of assurance of sterilityVita Pharmacy, LLC dba Talon Compounding Pharmacy / 3 vialsClass IIOngoing
D-0161-202210-12-2021TEST CYPIONATE 200MG/ANASTROZOLE 1MG/DUTASTERIDE 1MG/ML IN OIL INJECTABLE, Rx only, Talon Compounding Pharmacy, 2950 Thousand Oaks Drive Ste 25, San Antonio, Texas 78247Lack of assurance of sterilityVita Pharmacy, LLC dba Talon Compounding Pharmacy / 19 vialsClass IIOngoing
D-0108-202210-12-2021BLUE TREE LIPO EXTREME (/W METHYLCOBALAMIN) INJECTION INJECTABLE, Rx only, Talon Compounding Pharmacy, 2950 Thousand Oaks Drive Ste 25, San Antonio, Texas 78247Lack of assurance of sterilityVita Pharmacy, LLC dba Talon Compounding Pharmacy / 8 vialsClass IIOngoing
D-0110-202210-12-2021ESTRADIOL VALERATE 10MG/ML IN ETHYL OLEATE 10MG/ML INJECTABLE, Rx only, Talon Compounding Pharmacy, 2950 Thousand Oaks Drive Ste 25, San Antonio, Texas 78247Lack of assurance of sterilityVita Pharmacy, LLC dba Talon Compounding Pharmacy / 2 vialsClass IIOngoing
D-0192-202210-12-2021TRI-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 78247Lack of assurance of sterilityVita Pharmacy, LLC dba Talon Compounding Pharmacy / 1 vialClass IIOngoing
D-0104-202210-12-2021ALPROSTADIL 40MCG/ML INJ 40MCG/ML INJECTABLE, Rx only, Talon Compounding Pharmacy, 2950 Thousand Oaks Drive Ste 25, San Antonio, Texas 78247Lack of assurance of sterilityVita Pharmacy, LLC dba Talon Compounding Pharmacy / 4 vialsClass IIOngoing
D-0210-202210-12-2021TRI-MIX PAPAVERINE 30/PHENTOLAMINE 1/PGE-1 5 INJ INJECTABLE, Rx only, Talon Compounding Pharmacy, 2950 Thousand Oaks Drive Ste 25, San Antonio, Texas 78247Lack of assurance of sterilityVita Pharmacy, LLC dba Talon Compounding Pharmacy / 2 vialsClass IIOngoing
D-0129-202210-12-2021MIC B COMPLEX INJ-MILES FORMULATION INJECTABLE, Rx only, Talon Compounding Pharmacy, 2950 Thousand Oaks Drive Ste 25, San Antonio, Texas 78247Lack of assurance of sterilityVita Pharmacy, LLC dba Talon Compounding Pharmacy / 1 vialClass IIOngoing
D-0170-202210-12-2021TESTOSTERONE CYPIONATE 200MG/ANASTROZOLE 0.25MG/ML IN OIL INJECTABLE, Rx only, Talon Compounding Pharmacy, 2950 Thousand Oaks Drive Ste 25, San Antonio, Texas 78247Lack of assurance of sterilityVita Pharmacy, LLC dba Talon Compounding Pharmacy / 4 vialsClass IIOngoing
D-0153-202210-12-2021TEST CYPIONATE 200MG/ANASTROZOLE 0.5MG/DUTASTERIDE 1.5MG/ML IN OIL INJECTABLE, Rx only, Talon Compounding Pharmacy, 2950 Thousand Oaks Drive Ste 25, San Antonio, Texas 78247Lack of assurance of sterilityVita Pharmacy, LLC dba Talon Compounding Pharmacy / 4 vialsClass IIOngoing
D-0198-202210-12-2021TRI-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 78247Lack of assurance of sterilityVita Pharmacy, LLC dba Talon Compounding Pharmacy / 1 vialClass IIOngoing
D-0119-202210-12-2021IC B COMPLEX INJ INJECTABLE, Rx only, Talon Compounding Pharmacy, 2950 Thousand Oaks Drive Ste 25, San Antonio, Texas 78247Lack of assurance of sterilityVita Pharmacy, LLC dba Talon Compounding Pharmacy / 1 vialClass IIOngoing
D-0102-202210-12-2021ALPROSTADIL 30MCG/ML INJ 30MCG/ML INJECTABLE, Rx only, Talon Compounding Pharmacy, 2950 Thousand Oaks Drive Ste 25, San Antonio, Texas 78247Lack of assurance of sterilityVita Pharmacy, LLC dba Talon Compounding Pharmacy / 3 vialsClass IIOngoing
D-0209-202210-12-2021TRI-MIX PAPAVERINE 30/PHENTOLAMINE 1/PGE-1 40 INJ INJECTABLE, Rx only, Talon Compounding Pharmacy, 2950 Thousand Oaks Drive Ste 25, San Antonio, Texas 78247Lack of assurance of sterilityVita Pharmacy, LLC dba Talon Compounding Pharmacy / 4 vialsClass IIOngoing
D-0201-202210-12-2021TRI-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 78247Lack of assurance of sterilityVita Pharmacy, LLC dba Talon Compounding Pharmacy / 1 vialClass IIOngoing
D-0109-202210-12-2021CJC-1295 4MG/IPAMORELIN 4MG VIAL 4MG/4MG INJECTABLE, Rx only, Talon Compounding Pharmacy, 2950 Thousand Oaks Drive Ste 25, San Antonio, Texas 78247Lack of assurance of sterilityVita Pharmacy, LLC dba Talon Compounding Pharmacy / 15 vialsClass IIOngoing
D-0100-202210-12-2021ALPROSTADIL 22MCG/ML 22MCG/ML INJECTABLE, Rx only, Talon Compounding Pharmacy, 2950 Thousand Oaks Drive Ste 25, San Antonio, Texas 78247Lack of assurance of sterilityVita Pharmacy, LLC dba Talon Compounding Pharmacy / 1 vialClass IIOngoing
D-0151-202210-12-2021TEST 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 78247Lack of assurance of sterilityVita Pharmacy, LLC dba Talon Compounding Pharmacy / 23 vialsClass IIOngoing
D-0144-202210-12-2021SERMORELIN ACETATE 6MG/IPAMORELIN 6MG - LYOPHILIZED 6MG/6MG VIAL, Rx only, Talon Compounding Pharmacy, 2950 Thousand Oaks Drive Ste 25, San Antonio, Texas 78247Lack of assurance of sterilityVita Pharmacy, LLC dba Talon Compounding Pharmacy / 11 vialsClass IIOngoing
D-0200-202210-12-2021TRI-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 78247Lack of assurance of sterilityVita Pharmacy, LLC dba Talon Compounding Pharmacy / 5 vialsClass IIOngoing
D-0223-202210-12-2021TRI-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 78247Lack of assurance of sterilityVita Pharmacy, LLC dba Talon Compounding Pharmacy / 1 vialClass IIOngoing
D-0226-202210-12-2021TRI-MIX PAPAVERINE 40/PHENTOLAMINE 2/PGE-1 40 INJ INJECTABLE, Rx only, Talon Compounding Pharmacy, 2950 Thousand Oaks Drive Ste 25, San Antonio, Texas 78247Lack of assurance of sterilityVita Pharmacy, LLC dba Talon Compounding Pharmacy / 1 vialClass IIOngoing
D-0117-202210-12-2021HYDROXOCOBALAMIN 1,000MCG/ML INJ VIAL 1,000MCG/ML INJECTABLE, Rx only, Talon Compounding Pharmacy, 2950 Thousand Oaks Drive Ste 25, San Antonio, Texas 78247Lack of assurance of sterilityVita Pharmacy, LLC dba Talon Compounding Pharmacy / 2 vialsClass IIOngoing
D-0097-202210-12-2021Estradiol 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 78247Lack of assurance of sterilityVita Pharmacy, LLC dba Talon Compounding Pharmacy / 335 vialsClass IIOngoing
D-0220-202210-12-2021TRI-MIX PAPAVERINE 30/PHENTOLAMINE 4/PGE-1 20 INJ INJECTABLE, Rx only, Talon Compounding Pharmacy, 2950 Thousand Oaks Drive Ste 25, San Antonio, Texas 78247Lack of assurance of sterilityVita Pharmacy, LLC dba Talon Compounding Pharmacy / 13 vialsClass IIOngoing
D-0216-202210-12-2021TRI-MIX PAPAVERINE 30/PHENTOLAMINE 3/PGE-1 100 INJ INJECTABLE, Rx only, Talon Compounding Pharmacy, 2950 Thousand Oaks Drive Ste 25, San Antonio, Texas 78247Lack of assurance of sterilityVita Pharmacy, LLC dba Talon Compounding Pharmacy / 1 vialClass IIOngoing
D-0179-202210-12-2021TESTOSTERONE CYPIONATE 200MG/ML INJ #1 IN ETHYL OLEATE INJECTABLE, Rx only, Talon Compounding Pharmacy, 2950 Thousand Oaks Drive Ste 25, San Antonio, Texas 78247Lack of assurance of sterilityVita Pharmacy, LLC dba Talon Compounding Pharmacy / 1229 vialsClass IIOngoing
D-0207-202210-12-2021TRI-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 78247Lack of assurance of sterilityVita Pharmacy, LLC dba Talon Compounding Pharmacy / 1 vialClass IIOngoing
D-0143-202210-12-2021SERMORELIN ACETATE 15MG/IPAMORELIN 15MG - LYOPHILIZED 15MG/15MG VIAL, Rx only, Talon Compounding Pharmacy, 2950 Thousand Oaks Drive Ste 25, San Antonio, Texas 78247Lack of assurance of sterilityVita Pharmacy, LLC dba Talon Compounding Pharmacy / 6 vialsClass IIOngoing
D-0136-202210-12-2021QUAD-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 78247Lack of assurance of sterilityVita Pharmacy, LLC dba Talon Compounding Pharmacy / 1 vialClass IIOngoing
D-0171-202210-12-2021TESTOSTERONE CYPIONATE 200MG/ANASTROZOLE 0.5MG/ML INJ #1 IN ETHYL OLEATE INJECTABLE, Rx only, Talon Compounding Pharmacy, 2950 Thousand Oaks Drive Ste 25, San Antonio, Texas 78247Lack of assurance of sterilityVita Pharmacy, LLC dba Talon Compounding Pharmacy / 94 vialsClass IIOngoing
D-0155-202210-12-2021TEST 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 78247Lack of assurance of sterilityVita Pharmacy, LLC dba Talon Compounding Pharmacy / 50 vialsClass IIOngoing
D-0180-202210-12-2021TESTOSTERONE CYPIONATE 200MG/ML INJ #2 IN SESAME OIL INJECTABLE, Rx only, Talon Compounding Pharmacy, 2950 Thousand Oaks Drive Ste 25, San Antonio, Texas 78247Lack of assurance of sterilityVita Pharmacy, LLC dba Talon Compounding Pharmacy / 43 vialsClass IIOngoing
D-0147-202210-12-2021TRI-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 78247Lack of assurance of sterilityVita Pharmacy, LLC dba Talon Compounding Pharmacy / 4 vialsClass IIOngoing
D-0159-202210-12-2021TEST 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 78247Lack of assurance of sterilityVita Pharmacy, LLC dba Talon Compounding Pharmacy / 13 vialsClass IIOngoing
D-0132-202210-12-2021MIC 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 78247Lack of assurance of sterilityVita Pharmacy, LLC dba Talon Compounding Pharmacy / 1 vialClass IIOngoing
D-0027-202210-08-2021Imipramine Pamoate Capsules 125 mg, 30-count bottle, Rx only, Manufactured for Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202 UNited States. Manufactured by: Lupin Limited, Pithampur, (M.P.) 454 775 India NDC# 68180-316-06
Package NDCs: 68180-314-06; 68180-314-01; 68180-315-06; 68180-315-01; 68180-316-01; 68180-316-06; 68180-317-06; 68180-317-01
Out of specification result observed in a dissolution test at the 9-month long term stability time point.Lupin Pharmaceuticals Inc. / 1,902 bottlesClass IIOngoing
D-0084-202210-05-2021Dr. Reddy's Ezetimibe and Simvastatin Tablets, 10 mg/40 mg, a) 30 count (NDC 43598-743-30), b) 90 count (NDC 43598-743-90) bottles, Rx Only, Manufactured by: Dr. Reddy's Laboratories LA LLC, Shreveport, LA 71106, USA, Distributed by: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540 USA
Package NDCs: 43598-742-30; 43598-742-90; 43598-742-10; 43598-744-30; 43598-744-90; 43598-744-10; 43598-743-30; 43598-743-90; 43598-743-05; 43598-745-30; 43598-745-90; 43598-745-05
Failed Excipient Specifications; product manufactured using an excipient found to be OOS for conductivityDr. Reddy's Laboratories, Inc. / a) 11,590 bottles b) 3,585 bottlesClass IIOngoing
D-0085-202210-05-2021Dr. Reddy's Ezetimibe and Simvastatin Tablets, 10 mg/40 mg, 500 count bottles, Rx Only, Manufactured by: Dr. Reddy's Laboratories LA LLC, Shreveport, LA 71106, USA, Distributed by: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540 USA NDC 43598-743-05
Package NDCs: 43598-742-30; 43598-742-90; 43598-742-10; 43598-744-30; 43598-744-90; 43598-744-10; 43598-743-30; 43598-743-90; 43598-743-05; 43598-745-30; 43598-745-90; 43598-745-05
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 bottleDr. Reddy's Laboratories, Inc. / 696 bottlesClass IIOngoing
D-0083-202210-05-2021Dr. Reddy's Ezetimibe and Simvastatin Tablets, 10 mg/80 mg, a) 30 count (NDC 43598-745-30), b) 90 count (NDC 43598-745-90), and c) 500 count (NDC 43598-745-05) bottles, Rx Only, Manufactured by: Dr. Reddy's Laboratories LA LLC, Shreveport, LA 71106, USA, Distributed by: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540 USA
Package NDCs: 43598-742-30; 43598-742-90; 43598-742-10; 43598-744-30; 43598-744-90; 43598-744-10; 43598-743-30; 43598-743-90; 43598-743-05; 43598-745-30; 43598-745-90; 43598-745-05
Failed Excipient Specifications; product manufactured using an excipient found to be OOS for conductivityDr. Reddy's Laboratories, Inc. / a) 3,444 bottles b) 469 bottles c) 142 bottlesClass IIOngoing
D-0081-202210-05-2021Dr. Reddy's Ezetimibe and Simvastatin Tablets, 10 mg/10 mg, a) 90 count (NDC 43598-742-90) and b) 1000 count (NDC 43598-742-10) bottles, Rx only, Manufactured by: Dr. Reddy's Laboratories LA LLC, Shreveport, LA 71106, USA, Distributed by: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540 USA, , packaged in bottles.
Package NDCs: 43598-742-30; 43598-742-90; 43598-742-10; 43598-744-30; 43598-744-90; 43598-744-10; 43598-743-30; 43598-743-90; 43598-743-05; 43598-745-30; 43598-745-90; 43598-745-05
Failed Excipient Specifications; product manufactured using an excipient found to be OOS for conductivityDr. Reddy's Laboratories, Inc. / a) 776 bottles, b) 84 bottlesClass IIOngoing
D-0026-202210-05-2021Omeprazole Delayed-Release Capsules, 20 mg* (equivalent to 20.6 mg omeprazole magnesium), 24 Hour, 14-count capsules per bottle within a carton, Distributed by Cardinal Health, Dublin, OH 43017, NDC 70000-0232-1
Package NDCs: 70000-0232-1; 70000-0232-2; 70000-0232-3
CGMP Deviations: Customer complaint for the presence of a staple co-mingled with capsules within the bottle.Dr. Reddy's Laboratories, Inc. / 8,976 bottlesClass IIOngoing
D-0082-202210-05-2021Dr. Reddy's Ezetimibe and Simvastatin Tablets, 10 mg/20 mg, a) 30 count (NDC 43598-744-30), b) 90 count (NDC 43598-744-90) bottles, Rx only, Manufactured by: Dr. Reddy's Laboratories LA LLC, Shreveport, LA 71106, USA, Distributed by: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540 USA
Package NDCs: 43598-742-30; 43598-742-90; 43598-742-10; 43598-744-30; 43598-744-90; 43598-744-10; 43598-743-30; 43598-743-90; 43598-743-05; 43598-745-30; 43598-745-90; 43598-745-05
Failed Excipient Specifications; product manufactured using an excipient found to be OOS for conductivityDr. Reddy's Laboratories, Inc. / a) 30,839 bottles, b) 3,830 bottlesClass IIOngoing
D-0096-202210-05-2021Cetirizine hydrochloride, 10 mg tablets, 90-count bottle, Distributed by: A-S Medications Solutions, Libertyville, IL 60048, Mfg: Major Pharmaceuticals, Livonia, MI 48152, NDC: 50090-5510-3
Package NDCs: 50090-5510-1; 50090-5510-3
Labeling: Not Elsewhere classified: Product was relabeled as 90 tablet count product although it was a manufacturer in a box with 30 tablet count tablets.A-S Medication Solutions LLC. / 72 bottlesClass IIIOngoing
D-0004-202210-04-2021Betaxolol Ophthalmic Solution, USP, 0.5%, (Betaxolol HCl 5.6 mg/mL), 5 mL dropper bottle, Rx only, Sterile, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. Carton NDC: 17478-705-10, Bottle NDC 17478-705-11
Package NDCs: 17478-705-25; 17478-705-10; 17478-705-11; 17478-705-12
Microbial Contamination of Sterile Products: Confirmed sterility failure identified during stability testing at the 12-month time point.Akorn, Inc. / 10,210 bottlesClass IIOngoing
D-0241-202210-01-2021Lotrimin 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
Package NDCs: 11523-4327-1
cGMP Deviations: manufactured at the same facility where other lots were found to be contaminated with benzene.Bayer Healthcare Pharmaceuticals Inc. / 1,801,332 cansClass IIOngoing
D-0251-202210-01-2021Tinactin (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 Healthcare LLC, Whippany, NJ 07981, UPC 3 11017 41005 9, NDC 11523-0165-3.
Package NDCs: 11523-0165-3
Chemical Contamination: presence of benzeneBayer Healthcare Pharmaceuticals Inc. / 4,990,860 cansClass IOngoing
D-0250-202210-01-2021Tinactin (Tolnaftate 1%) DEODORANT POWDER SPRAY NET WT 133g (4.6 OZ) can, Dist by: Bayer Healthcare LLC, Whippany, NJ 07981, UPC 3 11017 41000 4, NDC 11523-4162-1, Product of Finland 20006105
Package NDCs: 11523-4162-1
Chemical Contamination: presence of benzeneBayer Healthcare Pharmaceuticals Inc. / 738,432 cansClass IOngoing
D-0242-202210-01-2021Tinactin (Tolnaftate 1%) DEODORANT POWDER SPRAY NET WT 133g (4.6 OZ) can, labeled as (a) UPC 3 11017-410-00 4, NDC 11523-4162-1, Product of Finland 86568411; (b) UPC 3 11017 41000 4, NDC 11523-4162-1, Product of Finland 20006105; Dist by: Bayer Healthcare LLC, Whippany, NJ 07981
Package NDCs: 11523-4162-1; 11017-410-00
cGMP Deviations: manufactured at the same facility where other lots were found to be contaminated with benzene.Bayer Healthcare Pharmaceuticals Inc. / 738,432 cansClass IIOngoing
D-0248-202210-01-2021LOTRIMIN 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
Package NDCs: 11523-0544-2
Chemical Contamination: presence of benzeneBayer Healthcare Pharmaceuticals Inc. / 3,816,468 cansClass IOngoing
D-0247-202210-01-2021LOTRIMIN 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
Package NDCs: 11523-4140-2
Chemical Contamination: presence of benzeneBayer Healthcare Pharmaceuticals Inc. / 4,546,152 cansClass IOngoing
D-0236-202210-01-2021LOTRIMIN 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
Package NDCs: 11523-1272-2
cGMP Deviations: manufactured at the same facility where other lots were found to be contaminated with benzene.Bayer Healthcare Pharmaceuticals Inc. / 2,817,468 cansClass IIOngoing
D-0253-202210-01-2021Tinactin (Tolnaftate 1%) POWDER SPRAY NET WT 133g (4.6 oz) can, labeled as (a) Product of Ireland 86940418; (b)Product of Finland 20006106; Dist by: Bayer Healthcare LLC, Whippany, NJ 07981, Product of Finland, UPC 3 11017 41009 7, NDC 11523-0777-2.
Package NDCs: 11523-0777-2
Chemical Contamination: presence of benzeneBayer Healthcare Pharmaceuticals Inc. / 2,841,012 cansClass IOngoing
D-0239-202210-01-2021LOTRIMIN AF (Tolnaftate 1%) DAILY PREVENTION deodorant powder spray NET WT 133g (4.6 OZ) can, Dist by: Bayer Healthcare LLC, Whippany, NJ 07981, Product of Finland, UPC 0 41100 59036 7, NDC 11523-0010-1.
Package NDCs: 11523-0010-1; 11523-0010-2
cGMP Deviations: manufactured at the same facility where other lots were found to be contaminated with benzene.Bayer Healthcare Pharmaceuticals Inc. / 77,076 cansClass IIOngoing
D-0254-202210-01-2021LOTRIMIN 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
Package NDCs: 11523-0010-1; 11523-0010-2; 0004110059
cGMP Deviations: LOTRIMIN AF (Tolnaftate 1%) manufactured at the same facility where other lots were found to be contaminated with benzene.Bayer Healthcare Pharmaceuticals Inc. / 579,456 unitsClass IIOngoing
D-0246-202210-01-2021LOTRIMIN 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
Package NDCs: 11523-1272-2
Chemical Contamination: presence of benzeneBayer Healthcare Pharmaceuticals Inc. / 2,817,468 cansClass IOngoing
D-0244-202210-01-2021Tinactin (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
Package NDCs: 11523-0072-5
cGMP Deviations: manufactured at the same facility where other lots were found to be contaminated with benzene.Bayer Healthcare Pharmaceuticals Inc. / 592,416 cansClass IIOngoing
D-0252-202210-01-2021Tinactin (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
Package NDCs: 11523-0072-5
Chemical Contamination: presence of benzeneBayer Healthcare Pharmaceuticals Inc. / 592,416 cansClass IOngoing
D-0240-202210-01-2021LOTRIMIN AF (Tolnaftate 1%) DAILY PREVENTION deodorant powder spray, NET WT 160g (5.6 OZ) can, packaged as (a) single pack, UPC 0 41100 58720 6, NDC 11523-0010-2; (b) 3-pack, UPC 0 41100 58961 3; Dist by: Bayer Healthcare LLC, Whippany, NJ 07981, Product of Finland,
Package NDCs: 11523-0010-1; 11523-0010-2
cGMP Deviations: manufactured at the same facility where other lots were found to be contaminated with benzene.Bayer Healthcare Pharmaceuticals Inc. / 579,456 cansClass IIOngoing
D-0238-202210-01-2021LOTRIMIN 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, ,
Package NDCs: 11523-0544-2
cGMP Deviations: manufactured at the same facility where other lots were found to be contaminated with benzene.Bayer Healthcare Pharmaceuticals Inc. / 3,816,468 cansClass IIOngoing
D-0237-202210-01-2021LOTRIMIN 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
Package NDCs: 11523-4140-2
cGMP Deviations: manufactured at the same facility where other lots were found to be contaminated with benzene.Bayer Healthcare Pharmaceuticals Inc. / 4,546,152 cansClass IIOngoing
D-0243-202210-01-2021Tinactin (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 Healthcare LLC, Whippany, NJ 07981, UPC 3 11017 41005 9, NDC 11523-0165-3.
Package NDCs: 11523-0165-3
cGMP Deviations: manufactured at the same facility where other lots were found to be contaminated with benzene.Bayer Healthcare Pharmaceuticals Inc. / 4,990,860 cansClass IIOngoing
D-0249-202210-01-2021Lotrimin AF (Tolnaftate 1%) Daily Prevention deodorant powder spray, NET WT 160g (5.6 OZ) can, Dist by: Bayer Healthcare LLC, Whippany, NJ 07981, Product of Finland, UPC 0 41100 58720 6, NDC 11523-0010-2.
Package NDCs: 11523-0010-1; 11523-0010-2
Chemical Contamination: presence of benzeneBayer Healthcare Pharmaceuticals Inc. / 579,456 cansClass IOngoing
D-0245-202210-01-2021Tinactin (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.
Package NDCs: 11523-0777-2
cGMP Deviations: manufactured at the same facility where other lots were found to be contaminated with benzene.Bayer Healthcare Pharmaceuticals Inc. / 2,841,012 cansClass IIOngoing
D-0017-202209-30-2021Coppertone Pure & Simple baby 50 Sunscreen Spray (To Deliver) Zinc Oxide 24.08%, NET WT 5 OZ (142 g) can, Beiersdorf Inc., Wilton, CT 06897 UPC 0 72140 02881 7cGMP DeviationsBeiersdorf Inc / 14,748 cansClass IIOngoing
D-0015-202209-30-2021Coppertone Pure & Simple 50 Sunscreen Spray (To Deliver) Zinc Oxide 24.08%, NET WT 5 OZ (142 g) can, Beiersdorf Inc., Wilton, CT 06897 UPC 0 72140 02880 0cGMP DeviationsBeiersdorf Inc / 36,660 cansClass IIOngoing
D-0014-202209-30-2021Coppertone SPORT Sunscreen Spray 50, (To Deliver) Avobenzone 3%, Homosalate 10%, Octisalate 5%, Octocrylene 5%, NET WT 1.6 OZ (45 g) can, Beiersdorf Inc., Wilton, CT 06897 UPC 0 41100 00506 9Chemical contamination; presence of benzeneBeiersdorf Inc / 143,376 cansClass IOngoing
D-0013-202209-30-2021Coppertone SPORT MINERAL 50 Sunscreen Spray (To Deliver) Zinc Oxide 24.08%, NET WT 5 OZ (142 g) can, Beiersdorf Inc., Wilton, CT 06897 UPC 0 72140 02870 1Chemical contamination; presence of benzeneBeiersdorf Inc / 142,236 cansClass IOngoing
D-0010-202209-30-2021Coppertone Pure & Simple 50 Sunscreen Spray (To Deliver) Zinc Oxide 24.08%, NET WT 5 OZ (142 g) can, Beiersdorf Inc., Wilton, CT 06897 UPC 0 72140 02880 0Chemical contamination; presence of benzeneBeiersdorf Inc / 38,328 cansClass IOngoing
D-0011-202209-30-2021Coppertone Pure & Simple kids 50 Sunscreen Spray (To Deliver) Zinc Oxide 24.08%, NET WT 5 OZ (142 g) can, Beiersdorf Inc., Wilton, CT 06897 UPC 0 72140 02882 4Chemical contamination; presence of benzeneBeiersdorf Inc / 167,808 cansClass IOngoing
D-0012-202209-30-2021Coppertone Pure & Simple baby 50 Sunscreen Spray (To Deliver) Zinc Oxide 24.08%, NET WT 5 OZ (142 g) can, Beiersdorf Inc., Wilton, CT 06897 UPC 0 72140 02881 7Chemical contamination; presence of benzeneBeiersdorf Inc / 124,668 cansClass IOngoing
D-0016-202209-30-2021Coppertone Pure & Simple kids 50 Sunscreen Spray (To Deliver) Zinc Oxide 24.08%, NET WT 5 OZ (142 g) can, Beiersdorf Inc., Wilton, CT 06897 UPC 0 72140 02882 4cGMP DeviationsBeiersdorf Inc / 70,320 cansClass IIOngoing
D-0006-202209-27-2021Potassium Chloride Extended-Release Tablets, USP 10 mEq (750 mg), 500 Tablets, Rx Only, Manufactured by: Strides Shasun Limited, Bengaluru - 562106, India, Distributed by: Strides Pharma In., East Brunswick, NJ 08816, NDC 64380-861-07.
Package NDCs: 64380-860-06; 64380-860-07; 64380-860-08; 64380-861-06; 64380-861-07; 64380-861-08
Failed Dissolution SpecificationsStrides Pharma Inc. / 1813 bottlesClass IIOngoing
D-0002-202209-27-2021Artesunate for Injection, 110 mg/vial, packaged in a) 2x2 pack containing 2 Single-dose vials artesunate (73607-001-01) and 2 vials sterile diluent (NDC 73607-001-02) per carton (NDC 73607-001-11); 4x4 pack containing 4 Single-dose vials artesunate (73607-001-01) and 4 vials sterile diluent (NDC 73607-001-02) per carton (NDC 73607-001-10), Rx only, Mfg for: Amivas, LLC, 1209 Orange St., Wilmington, Delaware 19801.Lack of Assurance of Sterility: Air filter failed post integrity test leading to a lack of sterility assurance.AMIVAS (US), LLC / 292 cartonsClass IIOngoing
D-0009-202209-24-2021Glucagon Emergency Kit for Low Blood Sugar, Glucagon for Injection, 1 mg per vial; Diluent for Glucagon, 1 mL syringe. Rx only, Marketed by: Lilly USA, LLC, Indianapolis, IN 46285; Glucagon, NDC: 0002-8031-01
Package NDCs: 0002-8031-01; 0002-7529-01; 0002-7530-01
SUBPOTENT DRUG: Vial contained a liquid substance, instead of the expected powder substance. There was also a lack of full drug effect upon administration.Eli Lilly & Company / 19,174 syringesClass IOngoing