Status
Terminated
Drug Enforcement D-0877-2023
Failed Impurities/Degradation Specifications
Classification
Class III
Report Date
June 28, 2023
Termination Date
August 28, 2024
Product Information
- Product description
- Glycopyrrolate Tablets, USP, 1 mg, 100-count bottles, Rx Only, Distributed by: Aurobindo Pharma USA, Inc., East Windsor, NJ 08520, NDC 13107-014-01
- Product quantity
- —
- Reason for recall
- Failed Impurities/Degradation Specifications
- Recall initiation reason
- —
- Initial firm notification
- —
- Distribution pattern
- Nationwide within the United States
Location & Firm
- Recalling firm
- Aurolife Pharma, LLC
- Address
-
2400 US Highway 130
United States - Voluntary / Mandated
- —
- Status date
- —
Codes & Dates
- Recall number
- D-0877-2023
- Event ID
- 92379
- Recall initiation date
- May 18, 2023
- Center classification date
- June 20, 2023
- Code info
- Lot #: 01421038A1, Exp. Date 05/2023
- More code info
- —