FDA Recall D-0087-2023
Aurolife Pharma, LLC · Dayton, NJ
Class II Ongoing 1245 days on record
Moderate impact — Class II recall — temporary or medically reversible adverse health consequence possible; remote probability of serious adverse health consequence.
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
Recall record
- Recall number
D-0087-2023- Classification
- Class II
- Status
- Ongoing
- Voluntary or mandated
- Voluntary: Firm initiated
- Distribution
- Nationwide in the USA and Puerto Rico.
- Recall initiated
- 2022-12-16
- Classified by FDA Center
- 2022-12-22
- FDA published
- 2022-12-28
- Recalling firm
- Aurolife Pharma, LLC
- Firm location
- Dayton, NJ
Drug identification
- Brand name(s)
- GLYCOPYRROLATE
- Generic name(s)
- GLYCOPYRROLATE
- Manufacturer(s)
- Aurolife Pharma LLC
- NDC(s)
13107-014, 13107-015- Route(s)
- ORAL
Operational response
Class II recalls indicate possible temporary or reversible health consequences. Remove affected lots from active dispensing. Segregate inventory. Check the firm’s recall notification for guidance on patient outreach.
For the official FDA enforcement record, see FDA's Recall Search.