D-0325-2021 Class III Terminated
FDA drug recall D-0325-2021 was initiated by SUN PHARMACEUTICAL INDUSTRIES INC on March 25, 2021 and is designated Class III. Reason for recall: Failed Moisture Limits: Out of specification for water content The recall status is terminated (terminated April 14, 2022). Affected quantity: 2520 bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- April 14, 2021
- Initiation Date
- March 25, 2021
- Termination Date
- April 14, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 2520 bottles
Product Description
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.
Reason for Recall
Failed Moisture Limits: Out of specification for water content
Distribution Pattern
Nationwide in the USA
Code Information
Lot #JKU4639A, Exp 10/2022