Status
Terminated
Drug Enforcement D-0634-2024
Presence of Foreign Tablets; 3 fused tablets of Metformin ER 500 mg were found in bottle of Gabapentin Tablets
Classification
Class II
Report Date
August 14, 2024
Termination Date
June 12, 2025
Product Information
- 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
- Product quantity
- 11,808 500-count Bottles
- Reason for recall
- Presence of Foreign Tablets; 3 fused tablets of Metformin ER 500 mg were found in bottle of Gabapentin Tablets
- Recall initiation reason
- —
- Initial firm notification
- Letter
- Distribution pattern
- Nationwide in the USA
Location & Firm
- Recalling firm
- Granules Pharmaceuticals Inc.
- Address
-
3701 Concorde Pkwy
United States - Voluntary / Mandated
- Voluntary: Firm initiated
- Status date
- —
Codes & Dates
- Recall number
- D-0634-2024
- Event ID
- 95072
- Recall initiation date
- July 31, 2024
- Center classification date
- August 14, 2024
- Code info
- Lot 1380040A, Exp. date July 31, 2025
- More code info
- —