Recalls / Class II
Class IID-1171-2023
Product
Rasagiline Tablets 0.5mg, 30-count bottle, Rx only, Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A., NDC 0378-1270-93
- Affected lot / code info
- Lot #: 3112444, Exp 8/2023
Why it was recalled
Failed dissolution specifications - results obtained were below spec average.
Recalling firm
- Firm
- Aurobindo Pharma USA Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 279 Princeton Hightstown Rd, East Windsor, New Jersey 08520-1401
Distribution
- Quantity
- 9,890 bottles
- Distribution pattern
- USA nationwide
Timeline
- Recall initiated
- 2023-08-02
- FDA classified
- 2023-09-18
- Posted by FDA
- 2023-09-27
- Terminated
- 2024-08-19
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1171-2023. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.