FDA-Drug2024-08-14Class II

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

Granules Pharmaceuticals Inc.
Hazard

Presence of Foreign Tablets; 3 fused tablets of Metformin ER 500 mg were found in bottle of Gabapentin Tablets

Sold states
Nationwide in the USA
Affected count
11,808 500-count Bottles
Manufactured in
3701 Concorde Pkwy, Chantilly, VA, United States
Products
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

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0634-2024

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