FDA recall D-0634-2024

Granules Pharmaceuticals Inc. · Class II · drug

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

Distribution

Nationwide in the USA

Key facts

Status: Terminated
Initiation date: 2024-07-31
Report date: 2024-08-14
Termination date: 2025-06-12
Voluntary/Mandated: Voluntary: Firm initiated
Location: Chantilly, VA, United States

Primary source

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