Amedra Pharmaceuticals LLC recalls Dexedrine¿ (Dextroamphetamine Sulfate) Spansules¿ Sustained Release Capsules 15mg, 90 count bottle, Rx only, Manufacture
Recalled January 1, 2014 · FDA recall D-385-2014 · Amedra Pharmaceuticals
Hazard
Failed Dissolution Specifications: Out of Specification (OOS) test results for Hour-4 at the 32 month CRT Stability Level. · FDA Class II
Units
10,992 bottles
Sold at
Nationwide
Description
Failed Dissolution Specifications: Out of Specification (OOS) test results for Hour-4 at the 32 month CRT Stability Level.
Product
Dexedrine¿ (Dextroamphetamine Sulfate) Spansules¿ Sustained Release Capsules 15mg, 90 count bottle, Rx only, Manufactured by Catalent Pharma Solutions Winchester, KY 40391 for Amedra Pharmaceuticals, LLC Middlesex, NJ 08846, NDC 52054-514-09
Manufacturer(s)
Amedra Pharmaceuticals LLC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →