Class II
Terminated
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
- Recall Initiated
- July 3, 2018
- Posted
- July 25, 2018
- Recall Number
- D-0924-2018
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 2508 bottles
- Firm Location
- Cranbury, NJ, United States
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.
Distribution
AZ
Lot / Code Info
Lot #: JKT0042A, Exp 1/2021
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