Class III
Terminated
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.
This recall has been terminated (originally issued April 14, 2021).
- Recall Initiated
- March 25, 2021
- Posted
- April 14, 2021
- Recall Number
- D-0325-2021
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 2520 bottles
- Firm Location
- Princeton, NJ, United States
- Official Source
- View on FDA website ↗
Reason for Recall
Failed Moisture Limits: Out of specification for water content
Distribution
Nationwide in the USA
Lot / Code Info
Lot #JKU4639A, Exp 10/2022
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