Recall: D-0087-2023

Class II - Potentially Harmful

Class IIClassification

2022-12-16Initiated

OngoingStatus

Aurolife Pharma, LLCFirm

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

Failed Impurities/Degradation Specifications

Distribution

Nationwide in the USA and Puerto Rico.

Source: FDA drug enforcement report via openFDA (Voluntary: Firm initiated). If you take this product, talk to your pharmacist or doctor before stopping it.