Why it was recalled
Presence of Foreign Tablets; 3 fused tablets of Metformin ER 500 mg were found in bottle of Gabapentin Tablets
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
Lot numbers, UPCs & expiration codes
Lot 1380040A, Exp. date July 31, 2025
Where it was sold
Nationwide in the USA
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0634-2024
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Jul 31, 2024
- FDA report date
- Aug 14, 2024
- Quantity
- 11,808 500-count Bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Granules Pharmaceuticals Inc.
Original FDA data
Every field from FDA enforcement report D-0634-2024, exactly as published.
Show all FDA fields
- City
- Chantilly
- State
- VA
- Status
- Terminated
- Country
- United States
- Event ID
- 95072
- Address
- 3701 Concorde Pkwy
- Code information
- Lot 1380040A, Exp. date July 31, 2025
- Postal code
- 20151-1126
- Report date
- Aug 14, 2024
- Product type
- Drugs
- Recall number
- D-0634-2024
- Classification
- Class II
- Recalling firm
- Granules Pharmaceuticals Inc.
- Product quantity
- 11,808 500-count Bottles
- Termination date
- Jun 12, 2025
- Reason for recall
- Presence of Foreign Tablets; 3 fused tablets of Metformin ER 500 mg were found in bottle of Gabapentin Tablets
- Voluntary / mandated
- Voluntary: Firm initiated
- 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
- Distribution pattern
- Nationwide in the USA
- Recall initiation date
- Jul 31, 2024
- Initial firm notification
- Letter
- Center classification date
- Aug 14, 2024