Recalls / Class III
Class IIID-190-2013
Product
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.
- Brand name
- Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, Amphetamine Sulfate
- Generic name
- Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, Amphetamine Sulfate
- Active ingredients
- Amphetamine Aspartate Monohydrate, Amphetamine Sulfate, Dextroamphetamine Saccharate, Dextroamphetamine Sulfate
- Route
- Oral
- NDCs
- 0228-3059, 0228-3062, 0228-3063, 0228-3060, 0228-3064, 0228-3061
- FDA application
- ANDA077302
- Affected lot / code info
- Lot #: 50077231
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.
Recalling firm
- Firm
- Actavis Elizabeth LLC
- Manufacturer
- Actavis Pharma, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 200 Elmora Ave, N/A, Elizabeth, New Jersey 07207
Distribution
- Quantity
- 9,264 Bottles
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2013-02-13
- FDA classified
- 2013-03-07
- Posted by FDA
- 2013-03-13
- Terminated
- 2014-03-06
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-190-2013. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.