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Amedra Pharmaceuticals Recalls
4 recalls on record · March 6, 2013 to January 1, 2014 · Drugs
Recalls by year
13
14
Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
January 1, 2014DrugsFDA
Amedra Pharmaceuticals LLC recalls Dexedrine¿ (Dextroamphetamine Sulfate) Spansules¿ Sustained Release Capsules 15mg, 90 count bottle, Rx only, Manufacture
Hazard: Failed Dissolution Specifications: Out of Specification (OOS) test results for Hour-4 at the 32 month CRT Stability Level.
March 6, 2013DrugsFDA
Amedra Pharmaceuticals LLC recalls Dextroamphetamine Sulfate Extended Release Capsules, 5 mg, 90 capsules, Rx only, Manufactured by Catalent Pharma Solutio
Hazard: Failed Dissolution Specifications: The affected lots may not meet the specifications for dissolution over the product shelf life.
March 6, 2013DrugsFDA
Amedra Pharmaceuticals LLC recalls Dextroamphetamine Sulfate Extended Release Capsules, 5 mg, 90 capsules, Rx only, Manufactured by Catalent Pharma Solutio
Hazard: Failed Dissolution Specifications: The affected lots may not meet the specifications for dissolution over the product shelf life.
March 6, 2013DrugsFDA
Amedra Pharmaceuticals LLC recalls Dextroamphetamine Sulfate Extended Release Capsules, 5 mg, 90 capsules, Rx only, Manufactured by Catalent Pharma Solutio
Hazard: Failed Dissolution Specifications: The affected lots may not meet the specifications for dissolution over the product shelf life.