Data Composite

Recall D-0634-2024

US Class II Terminated · initiated 2024-07-31

Recalling firm

Granules Pharmaceuticals Inc., VA

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

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