D-0634-2024 Class II Terminated
FDA drug recall D-0634-2024 was initiated by Granules Pharmaceuticals Inc. on Jul 31, 2024 and is designated Class II. Reason for recall: Presence of Foreign Tablets; 3 fused tablets of Metformin ER 500 mg were found in bottle of Gabapentin Tablets The recall status is terminated (terminated Jun 12, 2025). Affected quantity: 11,808 500-count Bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- Aug 14, 2024
- Initiation Date
- Jul 31, 2024
- Termination Date
- Jun 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
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0634-2024
- openFDA file date
- Nov 3, 2026
- Loaded by RegDataLab
- Nov 4, 2026