Granules Pharmaceuticals Inc.: Drug Recall

Recall #D-0634-2024 · 07/31/2024

Class II: Risk

Recall Details

Recall Number
D-0634-2024
Classification
Class II
Product Type
Drug
Recalling Firm
Granules Pharmaceuticals Inc.
Status
Terminated
Date Initiated
07/31/2024
Location
Chantilly, VA, United States
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
11,808 500-count Bottles

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

Distribution Pattern

Nationwide in the USA

Other Recalls by Granules Pharmaceuticals Inc.

View all recalls by Granules Pharmaceuticals Inc. →

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.