FDA recall D-0087-2023

Aurolife Pharma, LLC · Class II · drug

Product

Glycopyrrolate Tablets, USP, 1 mg, 100 tablets, Rx Only, Distributed by: Aurobindo Pharma USA, Inc., East Windsor, NJ 08520, NDC 13107-014-01

Reason for recall

Failed Impurities/Degradation Specifications

Distribution

Nationwide in the USA and Puerto Rico.

Key facts

Status
Ongoing
Initiation date
2022-12-16
Report date
2022-12-28
Voluntary/Mandated
Voluntary: Firm initiated
Location
Dayton, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0087-2023