Labeling: Label Error on Declared Strength; Some cartons were incorrectly labeled as 0.125 mg instead of 0.25 mg. The blister strips inside the product carton reflect the correct strength of 0.25 mg.
Endo Pharmaceuticals
Failed Impurities/Degradation Specifications and Subpotent Drug: High Out of Specification results for a known and unknown impurity as well as low Out of Specification results for assay.
Labeling: Incorrect Instructions: Dosage information on the immediate container label incorrectly states "Two to four tablets four times daily." rather than the correct dosage of "Two tablets three times daily."
Lack of Assurance of Sterility: Defective container resulting in the lack of sterility assurance. ok thanks
Adulterated Presence of Foreign Tablets: Customer complaint that some Endocet 10 mg/325 mg tablets were found mixed in a bottle with Endocet 10 mg/650 mg tablets.