Drug product
Gabapentin Tablets, USP, 600 mg, 500-count bottles, Rx only, Manufactured by: Granules India Limited Hyderabad-500 081, India, Manufactured for: Granules Pharmaceuticals Inc., Chantilly, VA NDC 70010-227-05
D-0634-2024
Product summary
- Event
- Event 95072
- Status
- Terminated
- Classification
- Class II
- Quantity
- 11,808 500-count Bottles
- Official record key
drug-enforcement:D-0634-2024
Official wording
Reason: Presence of Foreign Tablets; 3 fused tablets of Metformin ER 500 mg were found in bottle of Gabapentin Tablets
Code information: Lot 1380040A, Exp. date July 31, 2025
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Foreign material or chemical contamination
Foreign Tablets