Akorn, Inc. is recalling 4,128 bottles of Triamcinolone Acetonide Lotion, USP 0.1% (60 mL) due to high out-of-specification results for an impurity. This prescription topical medication, marketed by VersaPharm Incorporated and manufactured by Ei LLC, may contain degradation products that exceed safety or quality limits. Consumers should stop using the affected lotion and contact their healthcare provider or pharmacist for guidance regarding potential alternatives.
The presence of high levels of an impurity or degradation product means the medication may not be as effective as intended or could potentially cause unexpected side effects or skin irritation, although specific adverse events were not detailed in the report.
Healthcare consultation and pharmacy refund.
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Sources: FDA iRES · Raw API Response
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