Home / Recalls / Taro Pharmaceuticals U.S.A., Inc. / D-0727-2022

D-0727-2022 Class III Terminated

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

Recall Details

Product Type
Drugs
Report Date
April 6, 2022
Initiation Date
February 25, 2022
Termination Date
September 9, 2024
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
768 tubes

Product Description

Clotrimazole and Betamethasone Dipropionate Cream USP, 1%/0.05%,15 g tubes, Rx only, Manufactured by: Taro Pharmaceuticals Industries Ltd. Haifa Bay, Israel 2624761, Distributed by: Taro Pharmaceuticals U.S.A., Inc. Hawthorne, NY 10532, NDC 51672-4048-1

Reason for Recall

Failed Content Uniformity Specifications: Out-of-specification result for the Betamethasone Dipropionate assay of a stability sample

Distribution Pattern

Product was distributed to one retail consignee in NY.

Code Information

Lot #: AC33883, Exp. Date June 2023

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-0375-2022 Class I — Clobetasol Propionate Ointment USP, 0.05%, 60g tubes, Rx only, Mfd. by: Taro Pha (December 15, 2021)
  • D-0246-2021 Class II — Nortriptyline HCl Capsules, USP equivalent to 10mg base Mfd. by: Taro Pharmaceut (January 8, 2021)
  • D-0158-2021 Class II — TopCare Health, Athlete's Foot Cream, Clotrimazole Cream USP, 1%, Antifungal, NE (November 17, 2020)
  • D-0156-2021 Class II — RiteAid Pharmacy RIngworm Cream, Clotrimazole Cream USP, 1%, Antifungal NET W 0. (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-0154-2021 Class II — Kroger Athlete's Foot Cream, Clotrimazole Cream USP, 1%, Antifungal, NET WT 0.5 (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-0153-2021 Class II — Kaiser Permanente Clotrimazole Cream USP, 1% Antifungal Cream, NET WT 1 oz (28.4 (November 17, 2020)
  • D-0151-2021 Class II — Equate Athlete's Foot, Clotrimazole USP 1%, Antifungal Cream, Packaged as a) NET (November 17, 2020)