14,806 recalls, newest first
Microbial Contamination of Non-Sterile Products: FDA laboratory analysis found product to be contaminated with various microorganisms including Enterobacter cloacae, Cronobacter sakazakii, Cronobacter dublinensis, among others.
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.
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
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