Class II · Moderate risk Terminated
Cyanocobalamin Injection
Reason Lack of Assurance of Sterility
FDA Drug Recalls
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Class II · Moderate risk Terminated
Coenzyme Q10 Injection
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Calcium Chloride Injection
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Biotin
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Betamethasone Acetate/Betamethasone
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Betamethasone Acetate/Betamethasone
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Betamethasone Acetate/Betamethasone
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
B-Complex 110 Injectable
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
AscorbiX
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
AscorbiX
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Alprostadil/Papaverine Hydrochloride/Phentolamine Mesylate…
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Alprostadil/Papaverine Hydrochloride/Phentolamine Mesylate…
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Alprostadil
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Alprostadil
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Alprostadil/Papaverine Hydrochloride/Phentolamine…
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Alprostadil/Papaverine Hydrochloride/Phentolamine…
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Alprostadil/Papaverine Hydrochloride/Phentolamine…
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Ranitidine 300 mg
Reason CGMP Deviations: Presence of NDMA impurity detected in product.
Class II · Moderate risk Terminated
Ranitidine 150 mg
Reason CGMP Deviations: Presence of NDMA impurity detected in product.
Class II · Moderate risk Terminated
Ranitidine Hydrochloride
Reason CGMP Deviations: Presence of NDMA impurity detected in product.
Class II · Moderate risk Terminated
Nystatin Oral Suspension
Reason Subpotent: Out of specification for assay at the 12-month time point.
Class III · Low risk Terminated
methylPREDNISolone Sodium Succinate For Injection
Reason Labeling: Incorrect Instructions: Vial label incorrectly instructs healthcare professional to reconstitute product with 16 mL rather than the correct volume of 8 mL of Bacteriostatic Water for Injection with Benzyl Alcohol.
Class II · Moderate risk Terminated
Testosterone Cypionate for Injection
Reason cGMP Deviations; released lots were manufactured under similar manufacturing conditions to a previously rejected OOS Lot.
Class II · Moderate risk Terminated
Testosterone Cypionate for Injection
Reason cGMP Deviations; released lots were manufactured under similar manufacturing conditions to a previously rejected OOS Lot.
Class II · Moderate risk Terminated
ranitidine hydrochloride
Reason CGMP Deviations: Received notice from supplier of potential -Nitrosodimethylamine (NDMA) amounts above established levels.