Presence of Foreign Tablets/Capsules
Actavis Elizabeth
Failed Impurities/Degradation Specifications: Out of specification for impurities.
Failed Impurities/Degradation Specifications: Out of specification for impurities.
Failed Impurities/Degradation Specifications: Out of specification for impurities.
Failed Impurities/Degradation Specifications: Out of specification for impurities.
Failed Dissolution Specifications
Failed Capsule/Tablet Specifications: Actavis has received several complaint for clumping and breaking of capsules with some bottles showing popped out bottle bottom (round bottom) and creased labels from one distribution center.
Failed Capsule/Tablet Specifications: Actavis has received several complaint for clumping and breaking of capsules with some bottles showing popped out bottle bottom (round bottom) and creased labels from one distribution center.
Failed Capsule/Tablet Specifications: Actavis has received several complaint for clumping and breaking of capsules with some bottles showing popped out bottle bottom (round bottom) and creased labels from one distribution center.
Failed Tablet/Capsule Specifications: Complaints were received for significant tablet erosion for Alprazolam 1 mg.
Failed Dissolution Specifications: Product did not meet specification requirements for dissolution.
Subpotent Drug: During routine stability testing one tablet was found with tablet weight below specification.
Failed Tablet/Capsule Specifications; partial tablet erosion resulting in tablet weights below specification in some tablets
Failed Dissolution Specification: This product recall is due to the product lot # 50077231 exceeding dissolution specifications. All other test specifications were met.