REGULATORY INTELLIGENCE·Recall
PAI Holdings Recalls Superpotent Guaifenesin and Codeine Phosphate Oral Solution: Supply Chain and Regulatory Implications
PAI Holdings, LLC initiated a Class III recall of 4,080 bottles of Guaifenesin and Codeine Phosphate Oral Solution due to superpotency and sodium benzoate preservative issues. This event underscores critical quality control vulnerabilities in OTC drug manufacturing. Procurement and regulatory teams must scrutinize supplier quality systems, especially for controlled substances, to mitigate supply chain risks and ensure patient safety.
90-Day Activity
PAI Holdings, LLC
PSPriya Subramaniam· Intelligence Analyst2025-02-12