Recall
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
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.

View original FDA notice →

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