FDA Drug Recalls

1,523 recalls · Class III, newest first

Class III · Low risk Terminated Apr 1, 2019

Tootsie Roll POP ORANGE SCENTED ANTIBACTERIAL HAND GEL (Ethyl Alcohol 62%), 1.35 fl oz / 40 mL, OTC, Distributed by: JFL…

Reason CGMP deviations: Stability testing was not conducted on manufactured sunscreen and hand sanitizer OTC products.

NingBo Huize Commodity Co.,Ltd. D-1535-2019

Class III · Low risk Terminated Apr 1, 2019

Texas Home Health Home Care Hospice Personal Care Hand Sanitizer (Ethyl Alcohol 62%), 0.33 oz/10 mL, OTC, Made in China

Reason CGMP deviations: Stability testing was not conducted on manufactured sunscreen and hand sanitizer OTC products.

NingBo Huize Commodity Co.,Ltd. D-1534-2019

Class III · Low risk Terminated Apr 1, 2019

festpak clearly fun SPF30 sunscreen lotion SPF 30 SUNSCREEN LOTION Active Ingredients Octinoxate 7.5%, Octisalate 2.0%…

Reason CGMP deviations: Stability testing was not conducted on manufactured sunscreen and hand sanitizer OTC products.

NingBo Huize Commodity Co.,Ltd. D-1533-2019

Class III · Low risk Terminated Apr 1, 2019

SPF 30 SUNSCREEN LOTION Active Ingredients Octinoxate 7.5%, Octisalate 2.0%, Oxybenzone 4.0% Titanium Dioxide 2.5% Sunscreen…

Reason CGMP deviations: Stability testing was not conducted on manufactured sunscreen and hand sanitizer OTC products.

NingBo Huize Commodity Co.,Ltd. D-1532-2019

Class III · Low risk Terminated Apr 1, 2019

Tootsie Roll POP GRAPE SCENTED ANTIBACTERIAL HAND GEL (Ethyl Alcohol 62%), 1.35 fl oz / 40 mL, OTC, Distributed By: JFL…

Reason CGMP deviations: Stability testing was not conducted on manufactured sunscreen and hand sanitizer OTC products.

NingBo Huize Commodity Co.,Ltd. D-1531-2019

Class III · Low risk Terminated Apr 1, 2019

Good to Go Hand Sanitizer (Ethyl Alcohol 62%), 1 FL OZ (30 mL), OTC, Made in China for Cashco Distributors Inc. 6430 N. E…

Reason CGMP deviations: Stability testing was not conducted on manufactured sunscreen and hand sanitizer OTC products.

NingBo Huize Commodity Co.,Ltd. D-1530-2019

Class III · Low risk Terminated Apr 1, 2019

Accent Care of New York Home Care Nursing Personal Care Hand Sanitizer (Ethyl Alcohol 62%), 0.33 oz/10 mL, OTC, Made in China

Reason CGMP deviations: Stability testing was not conducted on manufactured sunscreen and hand sanitizer OTC products.

NingBo Huize Commodity Co.,Ltd. D-1529-2019

Class III · Low risk Terminated Apr 1, 2019

Telmisartan and Amlodipine Tablets 80 mg/5 mg, 30 tablet bottle, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc…

Reason Failed Impurities/Degradation Specifications; 18 month long term stability study.

Lupin Pharmaceuticals Inc. NDC 68180-198-06 D-1121-2019

Class III · Low risk Terminated Mar 29, 2019

Clonidine HCL Injection, 1000 mcg/10mL (100 mcg/mL), 10 ML Single Dose Vial, Rx only, Manufactured for: X-Gen Pharmaceuticals…

Reason Labeling: Label Error on Declared Strength: Side carton panel incorrectly lists the concentration as "500 mcg Clonidine Hydrochloride" rather than…

X-Gen Pharmaceuticals Inc. NDC 39822-2000-1 D-1084-2019

Class III · Low risk Terminated Mar 28, 2019

Nystatin Oral Suspension, USP, 100,000 units per mL, 473 mL per bottle, Rx only, HI-TECH Pharmacal Co., Inc., Amityville, NY…

Reason Failed Impurities/Degradation Specifications: Out of Specification for an unknown impurity was observed during the 18 month stability testing.

Akorn, Inc. NDC 50383-587-16 D-1080-2019

Class III · Low risk Terminated Mar 26, 2019

Thallous Chloride TI 201 Injection, Specific Concentration: 37 MBq/mL (1 mCi/mL), Total Activity: 325.6 MBq (8.8 mCi) Volume: 8.8…

Reason Chemical Contamination: Trace amounts of an impurity was detected in the reagent used to manufacture finished product.

Medi-Physics Inc. dba GE Healthcare D-1134-2019

Class III · Low risk Terminated Mar 22, 2019

Biotin 10 mg/mL Injection, 30 mL vial, Rx only, 511 S. Harbor Blvd., Building. F, La Habra, CA 90631, 562-352-9630.

Reason Failed pH Specification: product does not meet pH label claim.

Auro Pharmacies Inc. DBA Central Drugs D-1082-2019

Class III · Low risk Terminated Mar 18, 2019

Diclofenac Sodium Topical Solution, 1.5% w/w, 5 FL. OZ. (150 mL) bottle, Rx Only, Manufactured for: Ingenus Pharmaceuticals, LLC…

Reason Defective Container: firm discovered samples stored horizontally as well as product quality complaints from customers for bottles leaking.

Ingenus Pharmaceuticals Llc NDC 50742-308-05 D-1058-2019

Class III · Low risk Terminated Mar 15, 2019

Repairwear Laser Focus Line Smoothing Cream Broad Spectrum SPF 15, packaged in a light green folding carton containing a 50 mL…

Reason Defective container: Ineffective seal between the cap and jar of the affected product.

Estee Lauder Inc D-1132-2019

Class III · Low risk Terminated Mar 15, 2019

Clindamycin Injection, USP, 900 mg/6 mL (150 mg/mL), 6 mL vial, Rx only, Distributed by: Alvogen, Inc., Pine Brook, NJ 07058 USA…

Reason Failed Impurities/Degradation Specifications: High out-of-specification (OOS) results were demonstrated for several specified impurities at the…

Pfizer Inc. NDC 47781-621-94 D-1072-2019

Class III · Low risk Terminated Mar 15, 2019

Clindamycin Injection, USP, 600 mg/ 4 mL (150 mg/mL), 4 mL vials, Rx only, Distributed by: Alvogen, Inc., Pine Brook, NJ 07058…

Reason Failed Impurities/Degradation Specifications: High out-of-specification (OOS) results were demonstrated for several specified impurities at the…

Pfizer Inc. NDC 47781-620-94 D-1071-2019

Class III · Low risk Terminated Mar 15, 2019

Clindamycin Injection, USP, 300 mg/ 2 mL (150 mg/mL), 2 mL vials, Rx only, Distributed by: Alvogen, Inc., Pine Brook, NJ 07058…

Reason Failed Impurities/Degradation Specifications: High out-of-specification (OOS) results were demonstrated for several specified impurities at the…

Pfizer Inc. NDC 47781-619-94 D-1070-2019

Class III · Low risk Terminated Mar 15, 2019

Cleocin Phosphate, clindamycin injection, USP, 900 mg/ 6 mL (150 mg/mL), 6 mL vial, Rx only, Distributed by Pharmacia & Upjohn…

Reason Failed Impurities/Degradation Specifications: High out-of-specification (OOS) results were demonstrated for several specified impurities at the…

Pfizer Inc. NDC 0009-3447-01 D-1069-2019

Class III · Low risk Terminated Mar 15, 2019

Cleocin Phosphate, clindamycin injection, USP, 600 mg/ 4 mL (150 mg/mL), 4 mL vial, Rx only, Distributed by Pharmacia & Upjohn…

Reason Failed Impurities/Degradation Specifications: High out-of-specification (OOS) results were demonstrated for several specified impurities at the…

Pfizer Inc. NDC 0009-3124-01 D-1068-2019

Class III · Low risk Terminated Mar 15, 2019

Cleocin Phosphate (clindamycin injection), USP, 300 mg/ 2 mL (150 mg/mL), 2 mL-vial, Rx only, Distributed by Pharmacia & Upjohn…

Reason Failed Impurities/Degradation Specifications: High out-of-specification (OOS) results were demonstrated for several specified impurities at the…

Pfizer Inc. NDC 0009-6582-02 D-1067-2019

Class III · Low risk Terminated Mar 13, 2019