Drug recall D-0924-2018
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
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.
Lots and codes
Lot #: JKT0042A, Exp 1/2021
Recall details
- Recalling firm
- Sun Pharmaceutical Industries, Inc., Cranbury, NJ
- Quantity
- 2508 bottles
- Distribution
- AZ
- Type
- Voluntary: Firm initiated
- Recall initiated
- July 3, 2018
- Terminated
- November 5, 2019
Related products
- Metformin hydrochloride – drug information
- NDC 62756-142 Metformin Hydrochloride · Metformin Hydrochloride 500 mg/1 · Sun Pharmaceutical Industries, Inc.