Sun Pharmaceutical Industries Inc. is recalling approximately 24,624 bottles of Fluocinolone Acetonide Solution Topical Solution USP, 0.01% (60-mL bottles). The recall was initiated because the product failed degradation specifications after testing revealed an out-of-specification result for a known impurity called 'Impurity D'. This prescription medication is distributed by Taro Pharmaceuticals Inc. and was sold nationwide in the United States.
The presence of impurities or degradation products above specified limits can potentially affect the safety or effectiveness of the medication. No specific injuries have been reported in the provided data.
You have 2 options:
Rx only; Distributed by Taro Pharmaceuticals Inc.
AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.
Sources: FDA iRES · Raw API Response
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