Why it was recalled
Stason Pharmaceuticals is recalling Selegiline HCl tablets, USP 5mg 60 count bottle due to an out of specification result for dissolution of stability samples.
Product description
Selegiline HCL Tablets USP 5mg, 60- count bottles, Rx only, Manufactured by: Stason Pharmaceuticals, Inc. Irvine, CA 92618 Distributed by: Libertas Pharma, Inc. Montgomery, AL 36117. NDC 51862-146-06
Lot numbers, UPCs & expiration codes
Lot #: 14F030, 14F031, 14F032, Exp. June 2017; 15G022, Exp. July 2018
Where it was sold
North Carolina
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-1479-2016
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Aug 23, 2016
- FDA report date
- Sep 14, 2016
- Quantity
- 17,013 units
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Stason Pharmaceuticals, Inc.
Original FDA data
Every field from FDA enforcement report D-1479-2016, exactly as published.
Show all FDA fields
- City
- Irvine
- State
- CA
- Status
- Terminated
- Country
- United States
- Event ID
- 75025
- Address
- 11 Morgan
- Code information
- Lot #: 14F030, 14F031, 14F032, Exp. June 2017; 15G022, Exp. July 2018
- Postal code
- 92618-2005
- Report date
- Sep 14, 2016
- Product type
- Drugs
- Recall number
- D-1479-2016
- Classification
- Class III
- Recalling firm
- Stason Pharmaceuticals, Inc.
- Product quantity
- 17,013 units
- Termination date
- Oct 23, 2017
- Reason for recall
- Stason Pharmaceuticals is recalling Selegiline HCl tablets, USP 5mg 60 count bottle due to an out of specification result for dissolution of stability samples.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Selegiline HCL Tablets USP 5mg, 60- count bottles, Rx only, Manufactured by: Stason Pharmaceuticals, Inc. Irvine, CA 92618 Distributed by: Libertas Pharma, Inc. Montgomery, AL 36117. NDC 51862-146-06
- Distribution pattern
- North Carolina
- Recall initiation date
- Aug 23, 2016
- Initial firm notification
- Letter
- Center classification date
- Sep 2, 2016