REGULATORY INTELLIGENCE·Product Recall
Winder Laboratories Initiates Nationwide Class II Recall for Phenazopyridine HCl Due to Phenobarbital Mix-Up
Winder Laboratories, LLC has issued a Class II nationwide recall for Phenazopyridine HCl Tablets USP 100 mg due to a critical product mix-up, with bottles containing Phenobarbital tablets. This event, impacting 5,676 bottles, mandates immediate supply chain review and underscores the imperative for robust quality control and supplier diversification to mitigate significant regulatory and patient safety risks.
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