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Recall Observatory FDA recall evidence

Drug product

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

D-0104-2021

November 06, 2020

Class II

Product summary

Firm
Jubilant Cadista Pharmaceuticals, Inc.
Event
Event 86698
Status
Terminated
Classification
Class II
Quantity
4,416 bottles
Official record key
drug-enforcement:D-0104-2021

Official wording

Reason: Failed Tablet/Capsule Specification

Code information: Lot# 20P0141, exp. date 02/2022

Distribution pattern: Product was distributed nationwide.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Failed Tablet/Capsule Specification