Status
Ongoing
Drug Enforcement D-0087-2023
Failed Impurities/Degradation Specifications
Classification
Class II
Report Date
December 28, 2022
Termination Date
—
Product Information
- Product description
- Glycopyrrolate Tablets, USP, 1 mg, 100 tablets, Rx Only, Distributed by: Aurobindo Pharma USA, Inc., East Windsor, NJ 08520, NDC 13107-014-01
- Product quantity
- 7344 bottles
- Reason for recall
- Failed Impurities/Degradation Specifications
- Recall initiation reason
- —
- Initial firm notification
- —
- Distribution pattern
- Nationwide in the USA and Puerto Rico.
Location & Firm
- Recalling firm
- Aurolife Pharma, LLC
- Address
-
2400 US Highway 130
United States - Voluntary / Mandated
- Voluntary: Firm initiated
- Status date
- —
Codes & Dates
- Recall number
- D-0087-2023
- Event ID
- 91319
- Recall initiation date
- December 16, 2022
- Center classification date
- December 22, 2022
- Code info
- Lots: 01422002A1, Expiry: 12/2023; 01421078A3, Expiry: 09/2023
- More code info
- —