Every FDA drug recall initiated in 2020, newest first, with its risk class, status and the reason the FDA recorded. Use the cause and risk filters to narrow the year down.
930 recalls, newest first.
Labeling: Label Mix-Up; potential for cartons labeled as Tranexamic Acid Injection, USP to contain vials of Amiodarone HCl Injection, USP and cartons labeled as Amiodarone HCl Injection, USP to contain vials of Tranexamic Acid Injection, USP.
Marketed without an Approved NDA/ANDA; product labeled to contain 0.56% methanol making it an unapproved new drug
Marketed without an Approved NDA/ANDA; product labeled to contain 0.56% methanol making it an unapproved new drug
Marketed without an Approved NDA/ANDA; product labeled to contain 0.56% methanol making it an unapproved new drug
Marketed without an Approved NDA/ANDA; product labeled to contain 0.56% methanol making it an unapproved new drug
Sub-potent Drug: Out-of-Specification assay results found at 3 month stability testing.
CGMP Deviations: All other lots are being recalled because they were manufactured under the same conditions as the product lots found to contain methanol.
Chemical Contamination: FDA analysis found the product contains methanol, additionally it is sub-potent for ethanol content.
Marketed Without an Approved NDA/ANDA: product lists methanol as an inactive ingredient on the label.
Failed Impurity /Degradation Specifications
Presence of Foreign Substance: product complaints were received by the firm for the presence of metal wire in the tablet(s).
Labeling: Label Mix Up: bottle labeled to contain Prednisone Tablets, USP 2.5 mg actually contained Prednisone Tablets, USP 10 mg
Failed Stability Specifications: Out of Specification result for enzyme activity levels noted during routine stability testing.
Labeling Not Elsewhere Classified: Product labeled to contain methanol
Labeling Not Elsewhere Classified: Product labeled to contain methanol
Subpotent drug
Chemical Contamination: Product contains methanol as an active ingredient and is sub-potent for ethanol.
Failed Tablet/Capsule Specification; complaint of bulging tablet
Lack of Assurance of Sterility
Lack of Assurance of Sterility
Lack of Assurance of Sterility
Lack of Assurance of Sterility
Lack of Assurance of Sterility
Lack of Assurance of Sterility
Lack of Assurance of Sterility