FDA recall D-0570-2023

The Harvard Drug Group · Class III · drug

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

Reason for recall

Product mixup: one foreign tablet found in product.

Distribution

USA Nationwide

Key facts

Status: Terminated
Initiation date: 2023-04-24
Report date: 2023-05-17
Termination date: 2024-04-30
Voluntary/Mandated: Voluntary: Firm initiated
Location: La Vergne, TN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0570-2023