Dexpanthenol Preservative Free 250mg/mL
Lack of Assurance of Sterility
Every FDA drug recall whose status is still Ongoing: the firm is still removing product from the market, or the FDA has not yet closed the file. Some were opened years ago and never formally terminated, so check the initiation date as well as the status.
2,760 recalls, newest first.
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
Lack of Assurance of Sterility
Lack of Assurance of Sterility
CGMP Deviations: Potential exposure to rodents and rodent activity in the distribution center.
Chemical contamination: Presence of benzene
Chemical contamination: Presence of benzene
Chemical contamination: Presence of benzene
Labeling - product contains undeclared ethyl alcohol
Labeling - product contains undeclared ethyl alcohol
Failed Tablet Specifications: Recall of this drug product was voluntarily initiated by the manufacturer due to a market complaint, which stated that a tablet in the sealed bottle was twice larger in size when compared to the remaining tablets. This complaint is second of its kind.
Subpotent Drug: FDA analysis has revealed some bottles of these products were sub potent for ethanol.
Subpotent Drug: FDA analysis has revealed some bottles of these products were sub potent for ethanol.
CGMP Deviation: Difficulty dispensing/does not dispense or dispensing liquid instead of foam.
Lack of Assurance of Sterility
MICROBIAL CONTAMINATION OF NON-STERILE PRODUCT: microbial contaminant identified as Pluralibacter gergoviae.
Superpotent Drug: Minimally superpotent
Superpotent Drug
Defective container: Out of specification for container integrity leading to bottles leaking.
Labeling; Label mix-up and Wrong Bar Code; back label incorrectly states active ingredient as Menthol with UPC 7 14132 00071 4 instead of Peppermint Oil and Sage Oil with UPC 7 14132 00073 8