July 2018 FDA Recall Metformin Hydrochloride by Sun Pharmaceutical Industries, Inc.
D-0924-2018 - Presence of foreign substance

This Class II drug recall was voluntarily initiated by Sun Pharmaceutical Industries, Inc. on July 3, 2018 for the product Metformin Hydrochloride. The FDA reported the reason for recall as presence of foreign substance. The product was distributed in AZ and the recall is currently terminated.

Recall Number: D-0924-2018

Reason for Recall
Presence of foreign substance: One lot fo Metformin Hydrochloride Extended Release Tablets, USP, 500 mg (500 Count) contains foreign matter identified as a piece of rubber glove detected in one tablet.
Initiated
07-03-2018
Reported
07-25-2018
Quantity
2508 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
80440
Classification About Classification
Relative degree of health hazard assigned by FDA.
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.
Terminated
Recalling Firm About Recalling Firm
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.
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
Termination Date About Termination Date
Date that FDA officially terminated the recall.
11-05-2019
Product Description About Product Description
Full technical description of the product.
Metformin Hydrochloride Extended Release Tablets, USP, 500 mg, packaged in a 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# : JKT0042A, Exp 1/2021

Affected Packages Involved in this Recall

62756-142-01 Metformin Hydrochloride
62756-142-02 Metformin Hydrochloride
62756-143-01 Metformin Hydrochloride