D-0104-2021 Class II Terminated

Recalled by Jubilant Cadista Pharmaceuticals, Inc. — Salisbury, MD

FDA drug recall D-0104-2021 was initiated by Jubilant Cadista Pharmaceuticals, Inc. on November 6, 2020 and is designated Class II. Reason for recall: Failed Tablet/Capsule Specification The recall status is terminated (terminated March 23, 2022). Affected quantity: 4,416 bottles.

Recall Details

Product Type
Drugs
Report Date
December 2, 2020
Initiation Date
November 6, 2020
Termination Date
March 23, 2022
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
4,416 bottles

Product Description

clomiPRAMINE Hydrochloride Capsules USP, 50 mg, 30-count bottle, Rx Only, Manufactured by: Jubilant Cadista Pharmaceuticals Inc., Salisbury, MD NDC 59746-711-30

Reason for Recall

Failed Tablet/Capsule Specification

Distribution Pattern

Product was distributed nationwide.

Code Information

Lot# 20P0141, exp. date 02/2022