Ultra Seal Extra Strength Headache Relief recall — FDA D-1513-2020
Failed Stability Specifications: Out-of-Specification (OOS) results for the Aspirin related compound Salicylic Acid was observed.
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Failed Stability Specifications: Out-of-Specification (OOS) results for the Aspirin related compound Salicylic Acid was observed.
CGMP Deviations: Light sensitive drug products repackaged in transparent/partially transparent pouches.
CGMP Deviations: Light sensitive drug products repackaged in transparent/partially transparent pouches.
Chemical Contamination: Product contains undeclared methanol.
Failed Content Uniformity: bulk lot used to make these two lots was found to have failed content uniformity.
cGMP Deviations.
Labeling: Incorrect or Missing Lot and/or Exp date on the individual transdermal pouches but not in the carton.
Subpotent Drug: Out-of-Specification potency results at the 30-day stability timepoint.
Failed Impurities/Degradation Specifications: Out of specification result observed in related substance test.
Failed Content Uniformity: bulk lot used to make these two lots was found to have failed content uniformity.
Chemical contamination: product contains elevated levels of undeclared lead.
Chemical contamination: product contains elevated levels of undeclared lead.
Chemical contamination: product contains elevated levels of undeclared lead.
Chemical contamination: product contains elevated levels of undeclared lead.
Chemical contamination: product contains elevated levels of undeclared lead.
Chemical contamination: product contains elevated levels of undeclared lead.
Chemical Contamination: product contains elevated levels of undeclared lead.
Chemical contamination: product contains elevated levels of undeclared lead.
Chemical contamination: product contains elevated levels of undeclared lead.
cGMP deviations
Chemical contamination: product contains elevated levels of undeclared lead.
Chemical contamination: product contains elevated levels of undeclared lead.
Chemical contamination: product contains elevated levels of undeclared lead.
Chemical contamination: product contains elevated levels of undeclared lead.
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