REGULATORY INTELLIGENCE·Warning Letter
FDA Class II Recall: Contract Pharmacal's Acetaminophen Commingling Exposes OTC Supply Chain Risks
Contract Pharmacal Corporation faced an FDA Class II recall (D-0858-2020) for Major Extra Strength Acetaminophen Tablets due to commingling with a prenatal supplement. This event, now terminated, highlights critical quality control vulnerabilities in high-volume OTC manufacturing. Procurement directors and supply chain VPs must reinforce supplier qualification and audit processes to mitigate patient safety risks and ensure product integrity across their pharmaceutical portfolios.
90-Day Activity