Amedra Pharmaceuticals recalls
FDA enforcement reports naming Amedra Pharmaceuticals LLC as the recalling firm.
- Recall reports
- 4
- Class I (serious)
- 0
- Most recent report
- Jan 1, 2014
- Jan 1, 2014Dexedrine¿ (Dextroamphetamine Sulfate) Spansules¿ Sustained Release Capsules 15mg, 90 c…Drug · Amedra Pharmaceuticals LLCFailed Dissolution Specifications: Out of Specification (OOS) test results for Hour-4 at the 32 month CRT Stability Level.Class II
- Mar 6, 2013Dextroamphetamine Sulfate Extended Release Capsules, 5 mg, 90 capsules, Rx only, Manufa…Drug · Amedra Pharmaceuticals LLCFailed Dissolution Specifications: The affected lots may not meet the specifications for dissolution over the product shelf life.Class II
- Mar 6, 2013Dextroamphetamine Sulfate Extended Release Capsules, 5 mg, 90 capsules, Rx only, Manufa…Drug · Amedra Pharmaceuticals LLCFailed Dissolution Specifications: The affected lots may not meet the specifications for dissolution over the product shelf life.Class II
- Mar 6, 2013Dextroamphetamine Sulfate Extended Release Capsules, 5 mg, 90 capsules, Rx only, Manufa…Drug · Amedra Pharmaceuticals LLCFailed Dissolution Specifications: The affected lots may not meet the specifications for dissolution over the product shelf life.Class II