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
Reported: August 14, 2024 Initiated: July 31, 2024 #D-0634-2024
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
Details
- Recalling Firm
- Granules Pharmaceuticals Inc.
- Units Affected
- 11,808 500-count Bottles
- Distribution
- Nationwide in the USA
- Location
- Chantilly, VA
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Granules Pharmaceuticals Inc.. Units affected: 11,808 500-count Bottles.
Why was this product recalled? ▼
Presence of Foreign Tablets; 3 fused tablets of Metformin ER 500 mg were found in bottle of Gabapentin Tablets
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on August 14, 2024. Severity: Moderate. Recall number: D-0634-2024.
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