Why it was recalled
Failed dissolution specifications - results obtained were below spec average.
Product description
Rasagiline Tablets 0.5mg, 30-count bottle, Rx only, Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A., NDC 0378-1270-93
Lot numbers, UPCs & expiration codes
Lot #: 3112444, Exp 8/2023
Where it was sold
USA nationwide
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-1171-2023
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Aug 2, 2023
- FDA report date
- Sep 27, 2023
- Quantity
- 9,890 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Aurobindo Pharma USA Inc.
Original FDA data
Every field from FDA enforcement report D-1171-2023, exactly as published.
Show all FDA fields
- City
- East Windsor
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 92948
- Address
- 279 Princeton Hightstown Rd
- Code information
- Lot #: 3112444, Exp 8/2023
- Postal code
- 08520-1401
- Report date
- Sep 27, 2023
- Product type
- Drugs
- Recall number
- D-1171-2023
- Classification
- Class II
- Recalling firm
- Aurobindo Pharma USA Inc.
- Product quantity
- 9,890 bottles
- Termination date
- Aug 19, 2024
- Reason for recall
- Failed dissolution specifications - results obtained were below spec average.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Rasagiline Tablets 0.5mg, 30-count bottle, Rx only, Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A., NDC 0378-1270-93
- Distribution pattern
- USA nationwide
- Recall initiation date
- Aug 2, 2023
- Initial firm notification
- Letter
- Center classification date
- Sep 18, 2023