Prescription Drugs

Lack of Assurance of Sterility

Lack of Assurance of Sterility

Lack of Assurance of Sterility

Lack of Assurance of Sterility: product sterility cannot be guaranteed.

Lack of Assurance of Sterility: product sterility cannot be guaranteed.

Lack of Assurance of Sterility: product sterility cannot be guaranteed.

Lack of Assurance of Sterility

CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable daily intake level of 9.82 parts per million.

Defective Delivery System: potential risk of rubber stopper particles clogging the needle and leading to underdosing

Defective Delivery System: potential risk of rubber stopper particles clogging the needle and leading to underdosing

Labeling: Incorrect or Missing Lot and/or Exp Date. The expiry date on the product label is incorrect. The label states an expiry date of 09/2021 when it should be 09/2020.

Failed Dissolution Specifications:

cGMP Deviations: firm reported finding metal particulate matter in the filling room near the tube feeder during the filling operation of the product. No particulates were identified in the product, but rather were identified on the filling line.

Failed Impurities/Degradation Specifications

Labeling: Incorrect or Missing Lot and/or Exp Date. The expiry date on the product label is incorrect. The label states an expiry date of 09/2021 when it should be 09/2020.

Defective Delivery System: potential risk of rubber stopper particles clogging the needle and leading to underdosing

Defective Delivery System: potential risk of rubber stopper particles clogging the needle and leading to underdosing

Temperature Abuse; Product stored and shipped outside of labeled storage requirements.

Failed Impurities/Degradation Specificattion

Failed Impurities/Degradation Specifications