Recalling firm
Granules Pharmaceuticals Inc.
Product type
Drug
Status
Terminated
Report date
2024-08-14
Distribution
Nationwide in the USA
Firm state
VA
Product quantity
11,808 500-count Bottles
Initiated by
Voluntary: Firm initiated
Reason for recall
Presence of Foreign Tablets; 3 fused tablets of Metformin ER 500 mg were found in bottle of Gabapentin Tablets
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
Code / lot info
Lot 1380040A, Exp. date July 31, 2025
Data: U.S. FDA openFDA enforcement API. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification.