FDAHealthJuly 31, 2024
Granules Pharmaceuticals Inc. — Gabapentin Tablets, USP, 600 mg, 500-count bottles, Rx only, Manufactured by: Granules India Limited Hyderabad-500 081, India, Manufactured for: Granules Pharmaceutical
⚠️ Presence of Foreign Tablets; 3 fused tablets of Metformin ER 500 mg were found in bottle of Gabapentin Tablets
Is this relevant to me?
- Geography
- Nationwide
- Source agency
- FDA
- Category
- Health
- Published
- July 31, 2024
Nationwide in the USA
What's affected?
- 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
- GABAPENTIN
- UPC
- 0370010228016
- Lot code
- 1380040A
Additional details
Lot 1380040A, Exp. date July 31, 2025
What should I do?
Recommended action
Class II recall. Voluntary: Firm initiated Quantity affected: 11,808 500-count Bottles.
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