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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Fluocinolone Acetonide Topical Solution is a prescription corticosteroid used to treat inflammatory skin conditions. It is labeled Rx-only with NDC 51672-1365-4 and distributed nationwide in 60-mL bottles.
An out-of-specification impurity D was detected in the affected lots. The notice does not quantify potential health effects.
This recall is not described as part of a broader industry pattern.
Consumers and healthcare providers must stop using the product. The recall is active nationwide.
Label on bottle includes NDC and lot numbers; expiration date is on the packaging.
Remedy details beyond stopping use are not specified. Expect further instructions by recall letter from the manufacturer.
Keep the recall notice, packaging, and all communications; document any adverse events and correspondence
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.
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Failed Viscosity Specifications: Out of Specification results, above the specification limit, in viscosity, noted during stability testing.
Failed Viscosity Specifications: Out of Specification results, above the specification limit, in viscosity, noted during stability testing.
Failed Viscosity Specifications: Out of Specification results, above the specification limit, in viscosity, noted during stability testing.