Why it was recalled
Failed Dissolution Specifications
Product description
Dextroamphetamine Sulfate Extended-Release Capsules, 10 mg, 90- count bottles, Rx Only Manufactured by: Actavis Elizabeth LLC Elizabeth, NJ 07207 USA; Distributed by: Actavis Pharma, Inc Parsippany, NJ 07054 USA NDC 45963-304-09
Lot numbers, UPCs & expiration codes
Lot #: 3803J141, Exp. 7/2016
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-1448-2016
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Jul 11, 2016
- FDA report date
- Aug 3, 2016
- Quantity
- 8,062 units
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Actavis Inc
Original FDA data
Every field from FDA enforcement report D-1448-2016, exactly as published.
Show all FDA fields
- City
- Parsippany
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 74713
- Address
- 400 Interpace Pkwy
- Code information
- Lot #: 3803J141, Exp. 7/2016
- Postal code
- 07054-1120
- Report date
- Aug 3, 2016
- Product type
- Drugs
- Recall number
- D-1448-2016
- Classification
- Class II
- Recalling firm
- Actavis Inc
- Product quantity
- 8,062 units
- Termination date
- Feb 16, 2017
- Reason for recall
- Failed Dissolution Specifications
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Dextroamphetamine Sulfate Extended-Release Capsules, 10 mg, 90- count bottles, Rx Only Manufactured by: Actavis Elizabeth LLC Elizabeth, NJ 07207 USA; Distributed by: Actavis Pharma, Inc Parsippany, NJ 07054 USA NDC 45963-304-09
- Distribution pattern
- Nationwide
- Recall initiation date
- Jul 11, 2016
- Initial firm notification
- Letter
- Center classification date
- Jul 26, 2016