ChemLifeIntel/Companies/Winder Laboratories, LLC

Winder Laboratories, LLC

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INTELLIGENCE

Showing 2 of 2 briefs on Winder Laboratories, LLC

REGULATORY INTELLIGENCE·Recall

Winder Laboratories Initiates Nationwide Recall of Morphine Sulfate Oral Solution Due to Labeling Error

Winder Laboratories, LLC has initiated a voluntary Class III recall of 3,528 bottles of Morphine Sulfate Oral Solution (ANDA211454) nationwide in the U.S. The recall (D-0223-2026) stems from a critical mispack where carton labels incorrectly stated bottle sizes. This event underscores the persistent need for robust quality control in pharmaceutical packaging operations.

90-Day Activity

Winder Laboratories, LLCMorphine Sulfate

MKMeera Krishnan· Senior Regulatory Intelligence Analyst

2025-12-17

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.

90-Day Activity

Winder Laboratories, LLCPhenazopyridine Hydrochloride

MKMeera Krishnan· Senior Regulatory Intelligence Analyst

2024-06-19 Product Recall