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Lack of Assurance of Sterility
CGMP Deviations: Potential exposure to rodents and rodent activity in the distribution center.
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.
Labeling - product contains undeclared ethyl alcohol
Elevated levels of lead
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.