Why it was recalled
Failed Dissolution Specification: This product recall is due to the product lot # 50077231 exceeding dissolution specifications. All other test specifications were met.
Product description
Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, Amphetamine Sulfate Extended-Release Capsules, 15 mg, Rx Only, C II, 100 capsules per bottle, MFG. By Actavis Elizabeth LLC. 200 Elmora Ave, Elizabeth, NJ, 07207, USA, NDC 0228-3063-11.
Lot numbers, UPCs & expiration codes
Lot #: 50077231
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-190-2013
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Feb 13, 2013
- FDA report date
- Mar 13, 2013
- Quantity
- 9,264 Bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Actavis Elizabeth LLC
Original FDA data
Every field from FDA enforcement report D-190-2013, exactly as published.
Show all FDA fields
- City
- Elizabeth
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 64506
- Address
- 200 Elmora Ave
- Code information
- Lot #: 50077231
- Postal code
- 07207
- Report date
- Mar 13, 2013
- Product type
- Drugs
- Recall number
- D-190-2013
- Classification
- Class III
- Recalling firm
- Actavis Elizabeth LLC
- Product quantity
- 9,264 Bottles
- Termination date
- Mar 6, 2014
- Reason for recall
- Failed Dissolution Specification: This product recall is due to the product lot # 50077231 exceeding dissolution specifications. All other test specifications were met.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, Amphetamine Sulfate Extended-Release Capsules, 15 mg, Rx Only, C II, 100 capsules per bottle, MFG. By Actavis Elizabeth LLC. 200 Elmora Ave, Elizabeth, NJ, 07207, USA, NDC 0228-3063-11.
- Distribution pattern
- Nationwide
- Recall initiation date
- Feb 13, 2013
- Initial firm notification
- Letter
- Center classification date
- Mar 7, 2013