FDAFDA · Food and drugs·Recall number D-190-2013
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.
Published March 13, 2013 · Recall initiated: February 13, 2013
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Failed Dissolution Specification: This product recall is due to the product lot # 50077231 exceeding dissolution specifications. All other test specifications were met.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Brand
- DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, DEXTROAMPHETAMINE SULFATE, AMPHETAMINE SULFATE
- Manufacturer
- Actavis Elizabeth LLC
- Distributor
- Nationwide
- UPC
- 0302283064114
- Lot
- Lot #: 50077231
- Risk classification
- Class III
- Area (FDA)
- drug
- Country
- United States
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