FDA recall D-0877-2023

Aurolife Pharma, LLC · Class III · drug

Product

Glycopyrrolate Tablets, USP, 1 mg, 100-count bottles, 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 within the United States

Key facts

Status: Terminated
Initiation date: 2023-05-18
Report date: 2023-06-28
Termination date: 2024-08-28
Voluntary/Mandated: —
Location: Dayton, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0877-2023