clomiPRAMINE Hydrochloride Capsules USP, 50 mg, 30-count bottle, Rx Only, Manufactured by: Jubila...

FDA Recall #D-0104-2021 — Class II — November 6, 2020

Recall #D-0104-2021 Date: November 6, 2020 Classification: Class II Status: Terminated

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

Recalling Firm

Jubilant Cadista Pharmaceuticals, Inc. — Salisbury, MD

Classification

Class II — May cause temporary or medically reversible adverse health consequences.

Product Type

Drugs

Product Quantity

4,416 bottles

Distribution

Product was distributed nationwide.

Code Information

Lot# 20P0141, exp. date 02/2022

Status

Terminated

Voluntary / Mandated

Voluntary: Firm initiated