SUN PHARMACEUTICAL INDUSTRIES INC — Class II: Fluocinonide, USP, 0.05% Cream, 30g tube, Rx only, Mfd by: Taro Pharmaceuticals Inc., Bram
Sun Pharmaceutical Industries Inc. has initiated a Class II recall for Fluocinonide, USP, 0.05% Cream due to viscosity results that exceeded specification limits during stability testing.
This affects Sun Pharmaceutical Industries Inc., Taro Pharmaceuticals Inc., and distributors of the affected NDC (51672-1386-2), specifically impacting personnel in quality control, stability testing, and distribution.
Failure to meet viscosity specifications during stability suggests potential issues with product formulation stability or manufacturing consistency. While classified as Class II, indicating a remote probability of serious adverse health consequences, such deviations necessitate a root cause analysis to determine if the OOS result is batch-specific or indicative of broader process control challenges.
QA/QC units should review stability testing protocols for semi-solid dosage forms to ensure viscosity remains within specification throughout the product lifecycle. Regulatory teams should monitor ongoing recall statuses for potential impact on market supply and reporting requirements.
Class II. Reason: Failed Viscosity Specifications: Out of Specification results, above the specification limit, in viscosity, noted during stability testing.. Product: Fluocinonide, USP, 0.05% Cream, 30g tube, Rx only, Mfd by: Taro Pharmaceuticals Inc., Brampton, Ontario, Canada L6T 1C1, Dist. by: Taro Pharmaceuticals U.S.A., Inc., Hawthorne, NY 10532, NDC 51672-1386-2.. Firm: SUN PHARMACEUTICAL INDUSTRIES INC (Princeton NJ United States). Status: Ongoing.
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