Drug product
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.
D-0325-2021
Product summary
- Event
- Event 87617
- Status
- Terminated
- Classification
- Class III
- Quantity
- 2520 bottles
- Official record key
drug-enforcement:D-0325-2021
Official wording
Reason: Failed Moisture Limits: Out of specification for water content
Code information: Lot #JKU4639A, Exp 10/2022
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Potency or specification failure
Out of specification