Gabapentin Tablet, Film Coated
FDA Recall NDC 0904-7108
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 1 recorded enforcement report(s) associated with Gabapentin (NDC 0904-7108). A significant event, classified as Class III, was initiated on Apr 24, 2023 by Major Pharmaceuticals. The reported reason for this action was: "Product mixup: one foreign tablet found in product."
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
Reported Recall Events
Class III Terminated
Product mixup: one foreign tablet found in product.
Apr 24, 2023
May 17, 2023
3984 cartons
Recall Profile & Regulatory Data
Event ID
92174
Classification
Class III
Enforcement Status
Terminated
Recalling Firm
The Harvard Drug Group
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
USA Nationwide
Termination Date
Apr 30, 2024
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
Batch or Lot Expiration Information
Lot# Lot: T04468, Exp 10/2024
Affected Packages Involved in this Recall
0904-6823-61Product
0904-7108-61Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
