FDA recall D-0354-2023

Sciegen Pharmaceuticals Inc · Class III · drug

Product

Gabapentin Tablets, USP 600 mg, 500 tablets per bottle, RX Only, Manufactured by ScieGen Pharmaceuticals Inc., Hauppauge, NY 11788, NDC: 50228-177-05.

Reason for recall

Presence of Foreign Tablets/Capsules: Pharmacist reported presence of some Gabapentin tablets 800 mg comingled in Gabapentin 600 mg 500 count bottles.

Distribution

Nationwide in the USA and Puerto Rico

Key facts

Status: Terminated
Initiation date: 2023-02-17
Report date: 2023-03-08
Termination date: 2024-06-17
Voluntary/Mandated: Voluntary: Firm initiated
Location: Hauppauge, NY, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0354-2023