Class II · Moderate risk
Coenzyme Q10 Injection
Lack of Assurance of Sterility
FDA Drug Recalls
708 recalls · Class II, newest first
Class II · Moderate risk
Calcium Chloride Injection
Lack of Assurance of Sterility
Class II · Moderate risk
Biotin (Vitamin H)
Lack of Assurance of Sterility
Class II · Moderate risk
Betamethasone Acetate/Betamethasone
Lack of Assurance of Sterility
Class II · Moderate risk
Betamethasone Acetate/Betamethasone
Lack of Assurance of Sterility
Class II · Moderate risk
Betamethasone Acetate/Betamethasone
Lack of Assurance of Sterility
Class II · Moderate risk
B-Complex 110 Injectable
Lack of Assurance of Sterility
Class II · Moderate risk
AscorbiX (Buffered C)
Lack of Assurance of Sterility
Class II · Moderate risk
AscorbiX (Buffered C)
Lack of Assurance of Sterility
Class II · Moderate risk
Alprostadil/Papaverine Hydrochloride/Phentolamine Mesylate…
Lack of Assurance of Sterility
Class II · Moderate risk
Alprostadil/Papaverine Hydrochloride/Phentolamine Mesylate…
Lack of Assurance of Sterility
Class II · Moderate risk
Alprostadil
Lack of Assurance of Sterility
Class II · Moderate risk
Alprostadil
Lack of Assurance of Sterility
Class II · Moderate risk
Alprostadil/Papaverine Hydrochloride/Phentolamine Mesylate/Atropine Sulfate Injection
Lack of Assurance of Sterility
Class II · Moderate risk
Alprostadil/Papaverine Hydrochloride/Phentolamine Mesylate/Atropine Sulfate Injection
Lack of Assurance of Sterility
Class II · Moderate risk
Alprostadil/Papaverine Hydrochloride/Phentolamine Mesylate/Atropine Sulfate Injection
Lack of Assurance of Sterility
Class II · Moderate risk
Ranitidine 300 mg
CGMP Deviations: Presence of NDMA impurity detected in product.
Class II · Moderate risk
Ranitidine 150 mg
CGMP Deviations: Presence of NDMA impurity detected in product.
Class II · Moderate risk
Ranitidine Hydrochloride
CGMP Deviations: Presence of NDMA impurity detected in product.
Class II · Moderate risk
Nystatin Oral Suspension
Subpotent: Out of specification for assay at the 12-month time point.
Class II · Moderate risk
Testosterone Cypionate for Injection
cGMP Deviations; released lots were manufactured under similar manufacturing conditions to a previously rejected OOS Lot.
Class II · Moderate risk
Testosterone Cypionate for Injection
cGMP Deviations; released lots were manufactured under similar manufacturing conditions to a previously rejected OOS Lot.
Class II · Moderate risk
ranitidine hydrochloride
CGMP Deviations: Received notice from supplier of potential -Nitrosodimethylamine (NDMA) amounts above established levels.
Class II · Moderate risk
Netspot
Defective Container: loose aluminum cap crimp for the dilution buffer vial present in the NETSPOT Kit (vial 2).
Class II · Moderate risk