FDA recall D-0450-2022

Aurobindo Pharma USA Inc. · Class II · drug

Product

Pioglitazone Tablets USP, 45 mg, 500 count bottles, Distributed by: Aurobindo Pharma USA, Inc., East Windsor, NJ -- NDC 57237-221-05

Reason for recall

Superpotent and Failed Tablet/Capsule Specifications

Distribution

Nationwide in the US

Key facts

Status
Terminated
Initiation date
2021-12-29
Report date
2022-02-02
Termination date
2023-12-04
Voluntary/Mandated
Voluntary: Firm initiated
Location
East Windsor, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0450-2022