Gabapentin Tablets, USP 600 mg, packaged in Cartons of 100 tablets (10 tablets per blister pack x 10), Rx Only, Distribu
Summary
The FDA issued a Class III for Gabapentin Tablets, USP 600 mg, packaged in Cartons of 100 tablets (10 tablets p by The Harvard Drug Group. Reason: Product mixup: one foreign tablet found in product..
Details
Source
Drug Recall
External ID
D-0570-2023
Action Date
2023-05-17
Status
Terminated
Category
drug
Product Description
Gabapentin Tablets, USP 600 mg, packaged in Cartons of 100 tablets (10 tablets per blister pack x 10), Rx Only, Distributed by: Aurobindo Pharma USA, Inc. East Windsor, NJ 08520 Distributed by: Major Pharmaceuticals 17177 N Laurel Park Dr., Suite 233 Livonia, MI 48152 USA, NDC 0904-6823-61
Lot/Code Info: Lot: T04468, Exp 10/2024
Quantity Affected: 3984 cartons
Reason for Recall
Product mixup: one foreign tablet found in product.
Distribution
USA Nationwide
Type: Voluntary: Firm initiated
Recall Initiated: 2023-04-24
Company
La Vergne, TN
Context & Analysis
This is a Class III recall. Class III recalls involve products unlikely to cause adverse health consequences, but that violate FDA regulations.
This was one of 27 drug recalls issued in the same week, part of 272 drug-related FDA actions this month.
The Harvard Drug Group has 9 FDA actions in our database, including 9 recalls.
Frequently Asked Questions
What is a Class III recall?
A Class III recall involves products that are unlikely to cause adverse health effects but violate FDA labeling or manufacturing regulations.
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 (The Harvard Drug Group) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does The Harvard Drug Group have FDA actions?
The Harvard Drug Group has 9 FDA actions in our database, including 9 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0570-2023" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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