Home / Recalls / Taro Pharmaceuticals U.S.A., Inc. / D-0833-2020

D-0833-2020 Class I Terminated

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

FDA drug recall D-0833-2020 was initiated by Taro Pharmaceuticals U.S.A., Inc. on December 20, 2019 and is designated Class I. Reason for recall: Cross Contamination; Lamotrigine Tablets 100 mg USP was contaminated with enalapril maleate. The recall status is terminated (terminated February 23, 2024).

Recall Details

Product Type
Drugs
Report Date
February 19, 2020
Initiation Date
December 20, 2019
Termination Date
February 23, 2024
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity

Product Description

Lamotrigine Tablets, USP, 100 mg, Rx Only, 100-count bottle, Mfd. by: Taro Pharmaceutical Industries Ltd. Haifa Bay, Israel 2624761 Dist. by: Taro Pharmaceuticals U.S.A., Inc. Hawthorne, NY 10532, NDC 51672-4131-1.

Reason for Recall

Cross Contamination; Lamotrigine Tablets 100 mg USP was contaminated with enalapril maleate.

Distribution Pattern

Nationwide in the U.S. and Puerto Rico.

Code Information

Lot #: 331771, Exp. June 2021

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-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-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-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-0159-2021 Class II — Athlete's Foot Cream, Clotrimazole Cream USP, 1%, Antifungal Cream, NET WT 1 oz (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)

FDA data resources