D-0634-2024 Class II Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- August 14, 2024
- Initiation Date
- July 31, 2024
- Termination Date
- June 12, 2025
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 11,808 500-count Bottles
Product Description
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
Reason for Recall
Presence of Foreign Tablets; 3 fused tablets of Metformin ER 500 mg were found in bottle of Gabapentin Tablets
Distribution Pattern
Nationwide in the USA
Code Information
Lot 1380040A, Exp. date July 31, 2025