KRS Global Biotechnology Methylcobalamin 30 mL Vial-For SC / IM / IV Use, 30 mg / 30 mL recall — FDA D-0073-2020
Lack of Assurance of Sterility
Browse U.S. drug recall enforcement reports from the FDA in a structured, searchable format. Review the recalled product, reason, firm, status, dates, distribution information and FDA classification when available.
10,685 detailed records are currently available in this category.
Lack of Assurance of Sterility
Lack of Assurance of Sterility
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…
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…
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
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.
Microbial Contamination of Non-Sterile Products: products were found to be contaminated and above specification for lidocaine assay.
Superpotent Drug: products were found to be contaminated and above specification for lidocaine assay.
Failed Impurities/Degradation Specifications: High Out Of Specification results for impurities detected during routine stability testing.
Microbial Contamination of Non-Sterile Products: products were found to be contaminated and above specification for lidocaine assay.
Superpotent Drug: products were found to be contaminated and above specification for lidocaine assay.
Superpotent Drug: products were found to be contaminated and above specification for lidocaine assay.
Failed Impurities/Degradation Specifications
Superpotent Drug: products were found to be contaminated and above specification for lidocaine assay.
Subpotent Drug: Out of specification result during stability study in Pramipexole Dihydrochloride Tablets 0.125 mg
Lack of Assurance of Sterility
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