Prescription and over-the-counter medications
Colonia Care Pharmacy
Lack of Assurance of Sterility: product sterility cannot be guaranteed.
Colonia Care Pharmacy
Lack of Assurance of Sterility: product sterility cannot be guaranteed.
KRS Global Biotechnology
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.
Shire Human Genetic Therapies
Defective Delivery System: potential risk of rubber stopper particles clogging the needle and leading to underdosing
Shire Human Genetic Therapies
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.
cGMP Deviations: Potential glass contamination
Preferred Pharmaceuticals
Failed Impurities/Degradation Specifications
cGMP Deviations: Potential glass contamination
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.
cGMP Deviations: Potential glass contamination
Shire Human Genetic Therapies
Defective Delivery System: potential risk of rubber stopper particles clogging the needle and leading to underdosing
Shire Human Genetic Therapies
Defective Delivery System: potential risk of rubber stopper particles clogging the needle and leading to underdosing
Label Mix-Up: Product labeled as Quinacrine Dihydrochloride; however, after testing, identified as Artemisinin.
Temperature Abuse; Product stored and shipped outside of labeled storage requirements.
West-Ward Columbus
Failed Impurities/Degradation Specificattion
Microbial Contamination of Non-Sterile Products: products were found to be contaminated and above specification for lidocaine assay.