February 2023 FDA Recall Drug by Zydus Pharmaceuticals (usa) Inc (D-0467-2023 - Failed Impurities/Degradation Specifications)

This Class III drug recall was voluntarily initiated by Zydus Pharmaceuticals (usa) Inc on February 24, 2023 for the product Drug. The FDA reported the reason for recall as failed impurities/degradation specifications. The product was distributed in AZ, OH, MS. and the recall is currently terminated.

Recall Number: D-0467-2023

Reason for Recall
Failed Impurities/Degradation Specifications: An out-of-specification (OOS) result was observed during release testing of one lot for a related substance, i.e. Beta-lumicolchicine.
Initiated
02-24-2023
Reported
03-22-2023
Quantity
21,936/30 count bottles and 33,096/100 count bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
91770
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Zydus Pharmaceuticals (USA) Inc
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
AZ, OH, MS.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
07-01-2025
Product Description About Product Description
Full technical description of the product.
Colchicine Tablets, USP 0.6 mg, Rx Only, a) 30 tablets per bottle, NDC 16714-0039-01, b) 100 tablets per bottle, NDC 16714-0039-02, Manufactured for: NorthStar Rx LLC., Memphis, TN 38141, Manufactured by: Zydus Lifesciences Ltd., Ahmedabad, India, c) 100 tablets per bottle, NDC 70710-1351-01, Manufactured by: Cadila Healthcare Ltd., Ahmedabad, India, Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534.

Batch or Lot Expiration Information

Lot# s: a) E203821, Exp. 05/2024; b) E203822, Exp. 05/2024, E206186, Exp. 10/2024; c) E203820, Exp. 05/2024.