Status
Terminated
Drug Enforcement D-1171-2023
Failed dissolution specifications - results obtained were below spec average.
Classification
Class II
Report Date
September 27, 2023
Termination Date
August 19, 2024
Product Information
- Product description
- Rasagiline Tablets 0.5mg, 30-count bottle, Rx only, Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A., NDC 0378-1270-93
- Product quantity
- 9,890 bottles
- Reason for recall
- Failed dissolution specifications - results obtained were below spec average.
- Recall initiation reason
- —
- Initial firm notification
- Letter
- Distribution pattern
- USA nationwide
Location & Firm
- Recalling firm
- Aurobindo Pharma USA Inc.
- Address
-
279 Princeton Hightstown Rd
United States - Voluntary / Mandated
- Voluntary: Firm initiated
- Status date
- —
Codes & Dates
- Recall number
- D-1171-2023
- Event ID
- 92948
- Recall initiation date
- August 2, 2023
- Center classification date
- September 18, 2023
- Code info
- Lot #: 3112444, Exp 8/2023
- More code info
- —