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

FDA recall notice · announced December 28, 2022 · Aurolife Pharma

Class II FDA/FSIS Class II: use may cause temporary or medically reversible adverse health consequences.

The 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

Notes

Distribution: Nationwide in the USA and Puerto Rico.
Lot/code information: Lots: 01422002A1, Expiry: 12/2023; 01421078A3, Expiry: 09/2023
Quantity: 7344 bottles
Status: Ongoing
Products in this recall event:
- Glycopyrrolate Tablets, USP, 1 mg, 100 tablets, Rx Only, Distributed by: Aurobindo Pharma USA, Inc., East Windsor, NJ 08520, NDC 13107-014-01 (D-0087-2023)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.