April 2023 FDA Recall Gabapentin by The Harvard Drug Group
D-0570-2023 - Product mixup
This Class III drug recall was voluntarily initiated by The Harvard Drug Group on April 24, 2023 for the product Gabapentin. The FDA reported the reason for recall as product mixup. The product was distributed Nationwide and the recall is currently terminated.
Recall Number: D-0570-2023
Product mixup: one foreign tablet found in product.
04-24-2023
05-17-2023
3984 cartons
Recall Profile & Regulatory Data
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
The Harvard Drug Group
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
USA Nationwide
04-30-2024
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
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
