Amedra Pharmaceuticals LLC recalls Dextroamphetamine Sulfate Extended Release Capsules, 5 mg, 90 capsules, Rx only, Manufactured by Catalent Pharma Solutio
Recalled March 6, 2013 · FDA recall D-172-2013 · Amedra Pharmaceuticals
Hazard
Failed Dissolution Specifications: The affected lots may not meet the specifications for dissolution over the product shelf life. · FDA Class II
Units
12,948 bottles
Sold at
Nationwide and Puerto Rico.
Description
Failed Dissolution Specifications: The affected lots may not meet the specifications for dissolution over the product shelf life.
Product
Dextroamphetamine Sulfate Extended Release Capsules, 5 mg, 90 capsules, Rx only, Manufactured by Catalent Pharma Solutions for CorePharma, LLC Middlesex, NJ 08846 NDC 64720-328-09
Manufacturer(s)
Amedra Pharmaceuticals LLC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →