D-1171-2023 Class II Terminated
FDA drug recall D-1171-2023 was initiated by Aurobindo Pharma USA Inc. on August 2, 2023 and is designated Class II. Reason for recall: Failed dissolution specifications - results obtained were below spec average. The recall status is terminated (terminated August 19, 2024). Affected quantity: 9,890 bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- September 27, 2023
- Initiation Date
- August 2, 2023
- Termination Date
- August 19, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 9,890 bottles
Product Description
Rasagiline Tablets 0.5mg, 30-count bottle, Rx only, Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A., NDC 0378-1270-93
Reason for Recall
Failed dissolution specifications - results obtained were below spec average.
Distribution Pattern
USA nationwide
Code Information
Lot #: 3112444, Exp 8/2023