Nature Throid
Subpotent Drug: FDA analysis found product to be subpotent
1,463 recalls · Class I, newest first
Subpotent Drug: FDA analysis found product to be subpotent
Subpotent Drug: FDA analysis found product to be subpotent
Subpotent Drug: FDA analysis found product to be subpotent
Subpotent Drug: FDA analysis found product to be subpotent
Subpotent Drug: FDA analysis found product to be subpotent
Subpotent Drug: FDA analysis found product to be subpotent
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
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.
Chemical Contamination: Product contains methanol as an active ingredient and is sub-potent for ethanol.
Cross Contamination with Other Product(s): containers labeled as having methylparaben and propylparaben as preservatives, actually contained undeclared benzyl alcohol and did not contain any parabens.
Cross Contamination with Other Product(s): containers labeled as having methylparaben and propylparaben as preservatives, actually contained undeclared benzyl alcohol and did not contain any parabens.
Cross Contamination with Other Product(s): containers labeled as having methylparaben and propylparaben as preservatives, actually contained undeclared benzyl alcohol and did not contain any parabens.
Cross Contamination with Other Product(s): containers labeled as having methylparaben and propylparaben as preservatives, actually contained undeclared benzyl alcohol and did not contain any parabens.
Chemical Contamination: HERBACIL, Antiseptic Hand Sanitizer, 70% Alcohol, was found to be below the label claim for ethanol content and contained methanol.
Chemical Contamination: Born Basic Anti Bac was found to be below the label claim for ethanol content and contained methanol. Other products were recalled because they were manufactured in the same facility as the product found to contain methanol.
Cross Contamination with other products: trace amounts of lidocaine
Superpotent Drug
Superpotent Drug