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

FDA recall notice · announced June 28, 2023 · Aurolife Pharma

Class III FDA/FSIS Class III: use is not likely to cause adverse health consequences.

The 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

Notes

Distribution: Nationwide within the United States
Lot/code information: Lot #: 01421038A1, Exp. Date 05/2023
Status: Terminated
Products in this recall event:
- Glycopyrrolate Tablets, USP, 1 mg, 100-count bottles, Rx Only, Distributed by: Aurobindo Pharma USA, Inc., East Windsor, NJ 08520, NDC 13107-014-01 (D-0877-2023)

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