Lupin Pharmaceuticals Inc. is voluntarily recalling approximately 33,939 tubes of Nystatin and Triamcinolone Acetonide Cream USP (100,000 units/g, 0.1%). This prescription-only skin medication is being recalled because stability testing showed that the ingredients in the cream were not staying uniformly mixed over time when the tubes were stored upright. This defect can lead to the medicine being too strong or too weak in different parts of the tube, which may affect how well the treatment works or lead to unexpected skin reactions. If you use this medication, you should contact your doctor or pharmacist for guidance on continuing your treatment.
The ingredients in the cream failed to remain evenly distributed within the container during long-term storage, which means the medication may not deliver the correct dose of active ingredients to the skin. This could result in either a lack of treatment effectiveness for the skin condition or an increased risk of side effects if a portion of the cream contains a higher concentration of the steroid or antifungal medication than intended.
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Sources: FDA iRES · Raw API Response
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