Class II · Moderate risk
Betamethasone Acetate/Betamethasone
Lack of Assurance of Sterility
FDA Drug Recalls
832 recalls, newest first
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 III · Low risk
methylPREDNISolone Sodium Succinate For Injection
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
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 III · Low risk
Tri-Lo-Marzia
CGMP Deviations: Out of specification test result observed during retrospective review of blend uniformity test data.
Class II · Moderate risk
Class II · Moderate risk
Preferred Pharmaceuticals
CGMP Deviations: Presence of NDMA impurity detected in product.
Class II · Moderate risk
Preferred Pharmaceuticals
CGMP Deviations: Presence of NDMA impurity detected in product.