Home / Recalls / Taro Pharmaceuticals U.S.A., Inc. / D-0375-2022

D-0375-2022 Class I Terminated

Recalled by Taro Pharmaceuticals U.S.A., Inc. — Hawthorne, NY

FDA drug recall D-0375-2022 was initiated by Taro Pharmaceuticals U.S.A., Inc. on December 15, 2021 and is designated Class I. Reason for recall: Microbial Contamination of Non-Sterile Products: presence of R. Pickettii bacteria The recall status is terminated (terminated December 4, 2023). Affected quantity: 96 tubes.

Recall Details

Product Type: Drugs
Report Date: January 19, 2022
Initiation Date: December 15, 2021
Termination Date: December 4, 2023
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 96 tubes

Product Description

Clobetasol Propionate Ointment USP, 0.05%, 60g tubes, Rx only, Mfd. by: Taro Pharmaceutical Industries Ltd., Haifa Bay, Israel 2624761, Dist. by: Taro Pharmaceuticals U.S.A., Inc., Hawthorne, NY 10532. NDC 51672-1259-3

Reason for Recall

Microbial Contamination of Non-Sterile Products: presence of R. Pickettii bacteria

Distribution Pattern

Two distributors in UT and LA who could have further distributed to the retail level nationwide in the USA.

Code Information

Lot# AC13786, exp. date DEC 2022

Other recalls by Taro Pharmaceuticals U.S.A., Inc.

D-0633-2024 Class III — Hydrocortisone 1% & Acetic Acid 2% Otic Solution, 10 mL bottle, Rx only, Mfg by: (August 7, 2024)
D-0727-2022 Class III — Clotrimazole and Betamethasone Dipropionate Cream USP, 1%/0.05%,15 g tubes, Rx o (February 25, 2022)
D-0246-2021 Class II — Nortriptyline HCl Capsules, USP equivalent to 10mg base Mfd. by: Taro Pharmaceut (January 8, 2021)
D-0152-2021 Class II — H-E-B - Athlete's Foot Cream Clotrimazole Cream USP, 1% Anitfungal NET WT. 0.5 o (November 17, 2020)
D-0153-2021 Class II — Kaiser Permanente Clotrimazole Cream USP, 1% Antifungal Cream, NET WT 1 oz (28.4 (November 17, 2020)
D-0156-2021 Class II — RiteAid Pharmacy RIngworm Cream, Clotrimazole Cream USP, 1%, Antifungal NET W 0. (November 17, 2020)
D-0151-2021 Class II — Equate Athlete's Foot, Clotrimazole USP 1%, Antifungal Cream, Packaged as a) NET (November 17, 2020)
D-0157-2021 Class II — Best Choice, Clotrimazole Cream, USP 1%, Antifungal, NET WT 0.5 OZ (14.2g), Dist (November 17, 2020)
D-0159-2021 Class II — Athlete's Foot Cream, Clotrimazole Cream USP, 1%, Antifungal Cream, NET WT 1 oz (November 17, 2020)
D-0154-2021 Class II — Kroger Athlete's Foot Cream, Clotrimazole Cream USP, 1%, Antifungal, NET WT 0.5 (November 17, 2020)