Failed Dissolution Specifications: Out of Specification (OOS) test results for Hour-4 at the 32 month CRT Stability Level.
Amedra Pharmaceuticals
Class I - Dangerous
Failed Dissolution Specifications: The affected lots may not meet the specifications for dissolution over the product shelf life.
Class I - Dangerous
Failed Dissolution Specifications: The affected lots may not meet the specifications for dissolution over the product shelf life.
Class I - Dangerous
Failed Dissolution Specifications: The affected lots may not meet the specifications for dissolution over the product shelf life.