Class I - Dangerous
Failed Dissolution Specifications
Lannett Company
Presence of Foreign Tablet/Capsule: Two (2) bottles labeled as Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets, 10mg, 100ct, contained one (1) tablet of Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets, 5 mg.
Class I - Dangerous
Labeling: Label Mix-up. A bottle labeled as Lisdexamphetamine Dimesylate Capsules 40mg, contained Lisdexamphetamine Dimesylate Capsules 30mg.
Class I - Dangerous
Failed Content Uniformity Specifications: Product failed to meet the action limits for stratified content uniformity.
Failed Impurity/Degradation Specifications
Failed Impurity/Degradation Specifications
Class I - Dangerous
Failed Impurities/Degradation Specifications: Out of specification results for related substances.
Labeling: Label Mix Up: bottle labeled to contain Prednisone Tablets, USP 2.5 mg actually contained Prednisone Tablets, USP 10 mg
Class I - Dangerous
Microbial Contamination of Non-sterile Products: Out-of-specification results obtained for Total Aerobic Microbial Count.
Class I - Dangerous
CGMP Deviations: Presence of NDMA impurity detected in product.
Class I - Dangerous
Failed Dissolution Specifications
CGMP Deviations: cleaning procedures during manufacturing caused out of specification results for unknown impurities.