Why it was recalled
Failed Dissolution Specifications
Product description
Dextroamphetamine Sulfate Extended-Release Capsules, 15 mg, 90-count bottles, Rx Only, Manufactured by: Actavis Elizabeth LLC, Elizabeth, NJ 07201 USA; Distributed by: Actavis Pharma, Inc., Parsippany, NJ 07054 USA; NDC 45963-305-09, UPC 3 45963-305-09 1.
Lot numbers, UPCs & expiration codes
Lot #: 2020E141, Exp 07/15
Where it was sold
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-0395-2015
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Feb 10, 2015
- FDA report date
- Mar 11, 2015
- Quantity
- 42 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Actavis Elizabeth LLC
Original FDA data
Every field from FDA enforcement report D-0395-2015, exactly as published.
Show all FDA fields
- City
- Elizabeth
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 70522
- Address
- 200 Elmora Ave
- Code information
- Lot #: 2020E141, Exp 07/15
- Postal code
- 07202-1106
- Report date
- Mar 11, 2015
- Product type
- Drugs
- Recall number
- D-0395-2015
- Classification
- Class II
- Recalling firm
- Actavis Elizabeth LLC
- Product quantity
- 42 bottles
- Termination date
- Aug 14, 2015
- Reason for recall
- Failed Dissolution Specifications
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Dextroamphetamine Sulfate Extended-Release Capsules, 15 mg, 90-count bottles, Rx Only, Manufactured by: Actavis Elizabeth LLC, Elizabeth, NJ 07201 USA; Distributed by: Actavis Pharma, Inc., Parsippany, NJ 07054 USA; NDC 45963-305-09, UPC 3 45963-305-09 1.
- Distribution pattern
- Nationwide
- Recall initiation date
- Feb 10, 2015
- Initial firm notification
- Letter
- Center classification date
- Feb 27, 2015