Crown Laboratories is voluntarily recalling 98,205 tubes of Nystatin Cream (100,000 units per gram), an antifungal prescription medication used to treat skin infections. Testing during the 9-month interval revealed the medication was subpotent, meaning it fell out of the required specifications for its active ingredient assay. Because the medication is weaker than intended, it may not effectively treat the underlying fungal infection. These products were distributed nationwide across the United States in 15-gram and 30-gram tubes.
The subpotent nature of this cream means the active medication is not at the required strength, which may lead to treatment failure or a prolonged fungal infection for the patient. While no specific injuries or adverse events have been reported, using ineffective antifungal medication can allow an infection to persist or worsen.
Drug recall remedy
If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.
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Sources: FDA iRES · Raw API Response
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