Recalls / Class II
Class IID-0087-2023
Product
Glycopyrrolate Tablets, USP, 1 mg, 100 tablets, 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
- Lots: 01422002A1, Expiry: 12/2023; 01421078A3, Expiry: 09/2023
Why it was recalled
Failed Impurities/Degradation Specifications
Recalling firm
- Firm
- Aurolife Pharma, LLC
- Manufacturer
- Aurolife Pharma LLC
- Type
- Voluntary: Firm initiated
- Address
- 2400 US Highway 130, Dayton, New Jersey 08810-1519
Distribution
- Quantity
- 7344 bottles
- Distribution pattern
- Nationwide in the USA and Puerto Rico.
Timeline
- Recall initiated
- 2022-12-16
- FDA classified
- 2022-12-22
- Posted by FDA
- 2022-12-28
- Status
- Ongoing
Source: openFDA Drug Enforcement endpoint. Recall record D-0087-2023. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.