Drug recall D-0634-2024

Class II Terminated reported Aug 14, 2024

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

Reason for recall

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

Lots and codes

Lot 1380040A, Exp. date July 31, 2025

Recall details

Recalling firm
Granules Pharmaceuticals Inc., Chantilly, VA
Quantity
11,808 500-count Bottles
Distribution
Nationwide in the USA
Type
Voluntary: Firm initiated
Recall initiated
July 31, 2024
Terminated
June 12, 2025

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