Categories
Resources
Your Recalls
Loading...
Get email alerts when new recalls match your interests.
Subpotent drug: The potency of the active (menthol) was less than the label claim of 4%.
CGMP deviations
Microbial Contamination of Non-Sterile Products: confirmed presence of mold contamination
Marketed Without An Approved NDA/ANDA: FDA laboratory analysis found the product to contain undeclared diclofenac and methocarbamol,
Microbial Contamination of Non-Sterile Products - Presence of Acetobacter nitrogenifigens bacteria
Out of Specification for active ingredient
Out of Specification for active ingredient. Violative grade of propylene glycol used during the manufacturing process.
Chemical Contamination: Product manufactured with ethanol API that contains methanol
Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and/or tadalafil.
Lack of Assurance of Sterility
Product recalled due to the presence of yellow oleander and its components in the product.
CGMP Deviations: products may not conform to the labeled specifications.
Marketed without an approved NDA/ANDA: Product contains tianeptine, a substance not FDA-approved for any medical use in the United States.