FDA recall D-0653-2020

Product

Gabapentin Capsules, USP 100 mg, Rx Only, Distributed by: Aurobindo Pharma USA, Inc. Dayton, NJ 08810, NDC 65682-198-99

Reason for recall

Presence of Foreign Tablets/Capsules: One Losartan/HCTZ tablet was found in Gabapentin 1000 count bottles..

Distribution

Nationwide within the United States

Key facts

Status

Terminated

Initiation date

2019-11-19

Report date

2019-12-25

Termination date

2023-04-04

Voluntary/Mandated

Voluntary: Firm initiated

Location

East Windsor, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0653-2020