Sun Pharmaceutical Industries is recalling 24,624 bottles of Fluocinolone Acetonide Topical Solution nationwide after out-of-spec impurity D was detected. The product is distributed by Taro Pharmaceuticals in the United States and labeled Rx-only. Consumers must stop using the product and consult a healthcare provider for guidance.
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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Product: Fluocinolone Acetonide Topical Solution USP 0.01% in 60-mL bottles. NDC 51672-1365-4. Rx-only. Distributed by: Taro Pharmaceuticals Inc., Hawthorn, NY 10532. 24,624 bottles recalled. Sold nationwide in the USA. Lot numbers: AD81290, AD81291, AD81292, AD81293. Exp. Date: 1/31/2027.
The recall is due to out-of-specification results for known impurity D. No specific health effects are quantified in the notice. The FDA enforcement action classifies the recall as Class III with a high hazard level.
1. Stop using the product immediately. 2. Contact Sun Pharmaceutical Industries, Inc. or your healthcare provider for guidance. 3. Await further recall communications by letter from the manufacturer.
The recall directs consumers to contact Sun Pharmaceutical Industries, Inc. for guidance. No direct consumer phone number or hour-by-hour contact details are provided in the notice linked to the FDA enforcement page.
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