Drug product
Metoprolol Succinate Extended-Release Tablets, USP, 25 mg, Packaged in a) 100-count bottle, NDC 70010-780-01; b) 500-count bottle, NDC 70010-780-05; Rx only, Manufactured by: Granules India Limited, Hyderadab-500 081, India, Manufactured for: Granules Pharmaceuticals Inc., Chantilly, VA 20151,
D-0510-2025
Product summary
- Event
- Event 97131
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 27,648 100-count Bottles; 5,376 500-count Bottles
- Official record key
drug-enforcement:D-0510-2025
Official wording
Reason: Failed Dissolution Specifications: Product failed to meet dissolution acceptance criteria in the stability studies at the 6th month (25¿C/60% RH) long-term.
Code information: Lot # a)1400008A, Exp Date: 12/31/2025; b) 1400008B, Exp Date: 12/31/2025
Distribution pattern: Nationwide in the USA.
Derived failure modes
-
Potency or specification failure
Failed Dissolution Specifications