November 2020 FDA Recall Drug by Jubilant Cadista Pharmaceuticals, Inc.
D-0104-2021 - Failed Tablet/Capsule Specification
This Class II drug recall was voluntarily initiated by Jubilant Cadista Pharmaceuticals, Inc. on November 6, 2020 for the product Drug. The FDA reported the reason for recall as failed tablet/capsule specification. The product was distributed Nationwide and the recall is currently terminated.
Recall Number: D-0104-2021
Failed Tablet/Capsule Specification
11-06-2020
12-02-2020
4,416 bottles
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Jubilant Cadista Pharmaceuticals, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Product was distributed nationwide.
03-23-2022
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
clomiPRAMINE Hydrochloride Capsules USP, 50 mg, 30-count bottle, Rx Only, Manufactured by: Jubilant Cadista Pharmaceuticals Inc., Salisbury, MD NDC 59746-711-30
Batch or Lot Expiration Information
Lot# 20P0141, exp. date 02/2022
