Recalls / Class II
Class IID-0634-2024
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
- Brand name
- Gabapentin
- Generic name
- Gabapentin
- Active ingredient
- Gabapentin
- Route
- Oral
- NDCs
- 70010-227, 70010-228
- FDA application
- ANDA217116
- Affected lot / code info
- Lot 1380040A, Exp. date July 31, 2025
Why it was recalled
Presence of Foreign Tablets; 3 fused tablets of Metformin ER 500 mg were found in bottle of Gabapentin Tablets
Recalling firm
- Firm
- Granules Pharmaceuticals Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 3701 Concorde Pkwy, Chantilly, Virginia 20151-1126
Distribution
- Quantity
- 11,808 500-count Bottles
- Distribution pattern
- Nationwide in the USA
Timeline
- Recall initiated
- 2024-07-31
- FDA classified
- 2024-08-14
- Posted by FDA
- 2024-08-14
- Terminated
- 2025-06-12
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0634-2024. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.