1,709 recalls · Class III, newest first
Reason Mislabeling: The active ingredient list on the label does not match the product's actual ingredients Specifically, the label states Octinoxate 7.5% and Oxybenzone 3%, while the product therein is made with Octinoxate 7.5%, Octisalate 5%, Octocrylene 5%, and Avobenzone 3%.
Reason Presence Of Foreign Substance: Customer complaint for the presence of dark, gritty substance found within the bottle which was determined to be activated carbon from the desiccant canister inside the bottle.
Reason Presence Of Foreign Substance: Customer complaint for the presence of dark, gritty substance found within the bottle which was determined to be activated carbon from the desiccant canister inside the bottle.
Reason Subpotent drug: Low OOS for menthol content at the three month room temperature.
Reason Failed viscosity specification - product was below specificcation
Reason Does Not Meet USP or OTC Monograph: Product exceeds USP specification for alcohol content
Reason cGMP deviations: Temperature abuse
Reason Subpotent Drug: Out of specification for assay.
Reason Subpotent Drug: Out of Specification results for Assay
Reason Subpotent Drug and Presence of Particulate Matter: low out-of-specification results obtained for assay and the presence of particulate matter.
Reason Subpotent
Reason Labeling: Incorrect Barcode: Product barcode incorrectly identifies the product as rocuronium bromide injection 100 mg per 10 mL instead of sodium chloride injection 23.4%, 120 mEq per 30 mL.
Reason Incorrect/Undeclared Excipient: Product contains alcohol
Reason Subpotent Drug: low out-of-specification results for Vial 1 assay obtained during stability studies.
Reason Failed Impurities/Degradation Specifications: Out of Specification results for related substance.
Reason FAILED CONTENT UNIFORMITY SPECIFICATIONS
Reason Sub Potent
Reason Sub Potent
Reason Super Potent
Reason Sub Potent
Reason Subpotent Drug
Reason Subpotent Drug
Reason Subpotent Drug
Reason Subpotent Drug
Reason Subpotent Drug