Failed Impurities/Degradation Specifications: Out of specification result was obtained for the known impurity D.
Failed Impurities/Degradation Specifications: Out of specification result was obtained for the known impurity D.
Consumers and healthcare providers should stop using this product immediately. Contact SUN PHARMACEUTICAL INDUSTRIES INC or your healthcare provider for guidance. Notification method: Letter
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Fluocinolone Acetonide Solution Topical Solution USP, 0.01%, 60-mL bottles, Rx only, Dist. by: Taro Pharmaceuticals Inc., Hawthorn, NY 10532. NDC 51672-1365-4. Generic: FLUOCINOLONE ACETONIDE; Brand: FLUOCINOLONE ACETONIDE. Reason: Failed Impurities/Degradation Specifications: Out of specification result was obtained for the known impurity D.. Classification: Class III. Quantity: 24,624 bottles. Distribution: Nationwide within the USA
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