Home / Recalls / Taro Pharmaceuticals U.S.A., Inc. / D-0246-2021

D-0246-2021 Class II Terminated

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

FDA drug recall D-0246-2021 was initiated by Taro Pharmaceuticals U.S.A., Inc. on January 8, 2021 and is designated Class II. Reason for recall: CGMP deviations. The recall status is terminated (terminated September 7, 2023). Affected quantity: 44,256 bottles.

Recall Details

Product Type: Drugs
Report Date: February 10, 2021
Initiation Date: January 8, 2021
Termination Date: September 7, 2023
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 44,256 bottles

Product Description

Nortriptyline HCl Capsules, USP equivalent to 10mg base Mfd. by: Taro Pharmaceutical Industries Ltd. Haifa Bay, Israel 2624761 Dist. by: Taro Pharmaceuticals U.S.A., Inc. Hawthorne, NY 10532 NDC 51672-4001-1

Reason for Recall

CGMP deviations.

Distribution Pattern

Nationwide

Code Information

AC05096, AC05098, and AC05099; Exp 10/31/2022

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