Gabapentin Tablets, USP, 600 mg, 500-count bottles, Rx only, Manufactured by: Granules India Limited Hyderabad-500 081,
Summary
The FDA issued a Class II for Gabapentin Tablets, USP, 600 mg, 500-count bottles, Rx only, Manufactured by: Gr by Granules Pharmaceuticals Inc.. Reason: Presence of Foreign Tablets; 3 fused tablets of Metformin ER 500 mg were found in bottle of Gabapentin Tablets.
Details
Source
Drug Recall
External ID
D-0634-2024
Action Date
2024-08-14
Status
Terminated
Category
drug
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
Lot/Code Info: Lot 1380040A, Exp. date July 31, 2025
Quantity Affected: 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
Distribution
Nationwide in the USA
Type: Voluntary: Firm initiated
Recall Initiated: 2024-07-31
Company
Chantilly, VA
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 59 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
Granules Pharmaceuticals Inc. has 10 FDA actions in our database, including 10 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Granules Pharmaceuticals Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Granules Pharmaceuticals Inc. have FDA actions?
Granules Pharmaceuticals Inc. has 10 FDA actions in our database, including 10 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0634-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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