Approximately 4,152 tubes of Clocortolone Pivalate Cream, 0.1% (90-gram tubes) are being recalled. This prescription medication, used for skin conditions, failed stability testing because the cream's thickness (viscosity) did not meet the required quality standards. While the risk is considered low, the change in thickness may affect how the medication is dispensed or applied. No injuries or adverse effects have been reported in the recall notice.
During stability testing, the cream was found to be 'out-of-specification' for viscosity, meaning it became thinner or thicker than intended. This physical change can affect the consistency of the medication and its performance during application.
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Sources: FDA iRES · Raw API Response
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