March 2021 FDA Recall Metformin Hydrochloride by Sun Pharmaceutical Industries Inc
D-0325-2021 - Failed Moisture Limits
This Class III drug recall was voluntarily initiated by Sun Pharmaceutical Industries Inc on March 25, 2021 for the product Metformin Hydrochloride. The FDA reported the reason for recall as failed moisture limits. The product was distributed Nationwide and the recall is currently terminated.
Recall Number: D-0325-2021
Failed Moisture Limits: Out of specification for water content
03-25-2021
04-14-2021
2520 bottles
Recall Profile & Regulatory Data
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.
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.
SUN PHARMACEUTICAL INDUSTRIES 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.
Nationwide in the USA
04-14-2022
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Metformin HCl Extended-Release Tablets, USP, 500 mg, Rx Only, 500-count bottle, Rx only, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512; Manufactured by: Sun Pharmaceutical Industries Ltd., Halol-Baroda HIghway, Halol-389 350 Gujarat, India, NDC 62756-142-02.
Batch or Lot Expiration Information
Lot# JKU4639A, Exp 10/2022
