Recalls / Class III
Class IIID-0877-2023
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
- Brand name
- Glycopyrrolate
- Generic name
- Glycopyrrolate
- Active ingredient
- Glycopyrrolate
- Route
- Oral
- NDCs
- 13107-014, 13107-015
- FDA application
- ANDA202675
- Affected lot / code info
- Lot #: 01421038A1, Exp. Date 05/2023
Why it was recalled
Failed Impurities/Degradation Specifications
Recalling firm
- Firm
- Aurolife Pharma, LLC
- Manufacturer
- Aurolife Pharma LLC
- Address
- 2400 US Highway 130, Dayton, New Jersey 08810-1519
Distribution
- Distribution pattern
- Nationwide within the United States
Timeline
- Recall initiated
- 2023-05-18
- FDA classified
- 2023-06-20
- Posted by FDA
- 2023-06-28
- Terminated
- 2024-08-28
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0877-2023. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.