Gabapentin Tablets, USP 600 mg, packaged in Cartons of 100 tablets (10 tablets per blister pack x...

FDA Recall #D-0570-2023 — Class III — April 24, 2023

Recall #D-0570-2023 Date: April 24, 2023 Classification: Class III Status: Terminated

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

Reason for Recall

Product mixup: one foreign tablet found in product.

Recalling Firm

The Harvard Drug Group — La Vergne, TN

Classification

Class III — Not likely to cause adverse health consequences.

Product Type

Drugs

Product Quantity

3984 cartons

Distribution

USA Nationwide

Code Information

Lot: T04468, Exp 10/2024

Status

Terminated

Voluntary / Mandated

Voluntary: Firm initiated