FDAFDA · Food and drugs·Recall number D-171-2013
Dextroamphetamine Sulfate Extended Release Capsules, 5 mg, 90 capsules, Rx only, Manufactured by Catalent Pharma Solutions for CorePharma, LLC Middlesex, NJ 08846 NDC 64720-327-09
Published March 6, 2013 · Recall initiated: December 4, 2012
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 Specifications: The affected lots may not meet the specifications for dissolution over the product shelf life.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Amedra Pharmaceuticals LLC
- Distributor
- Nationwide and Puerto Rico.
- Lot
- Lot 238316, exp 01/31/2014
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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