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D-0863-2020 Class I Terminated

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

FDA drug recall D-0863-2020 was initiated by Taro Pharmaceuticals U.S.A., Inc. on February 7, 2020 and is designated Class I. Reason for recall: Resuspension Problems: Two lots of Phenytoin Oral Suspension USP 125mg/5mL may coagulate and may not resuspend as per the label copy instructions. The recall status is terminated (terminated December 11, 2023). Affected quantity: 29,172 8 Fl Oz bottles.

Recall Details

Product Type
Drugs
Report Date
March 4, 2020
Initiation Date
February 7, 2020
Termination Date
December 11, 2023
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
29,172 8 Fl Oz bottles

Product Description

Phenytoin Oral Suspension USP, 125 mg/5 mL potency, 8 fl oz (237 mL) Rx Only Mfd. by: Taro Pharmaceuticals Industries Ltd. Haifa Bay, Israel 2624761 Dist. by: Taro Pharmaceuticals U.S.A. Inc. Hawthorne, NY 10532, NDC 51672-4069-1

Reason for Recall

Resuspension Problems: Two lots of Phenytoin Oral Suspension USP 125mg/5mL may coagulate and may not resuspend as per the label copy instructions.

Distribution Pattern

Distributed Nationwide in the USA.

Code Information

Lot# 327874, 327876, Exp Dec/2020

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