CGMP Deviations
Eli Lilly & Company
SUBPOTENT DRUG: Vial contained a liquid substance, instead of the expected powder substance. There was also a lack of full drug effect upon administration.
Class I - Dangerous
Labeling: Label error on declared strength - autoinjector devices labeled as 0.75 mg / 0.5 mL actually contain 1.5 mg / 0.5 mL of product.
Class I - Dangerous
cGMP deviations: Atypical appearance, decrease in size and change in color of the lyophilized cake of drug product.