H J Harkins Company Inc dba Pharma Pac initiated a Class II recall of Ranitidine 150 mg Tablets due to NDMA impurity and CGMP deviations. This event, impacting distribution in CA, FL, NC, and SC, underscores persistent quality control challenges in pharmaceutical manufacturing and demands rigorous supply chain vigilance from industry leaders.
Glenmark Pharmaceuticals Inc., USA initiated a nationwide Class II recall of 500,960 bottles of Ranitidine Tablets USP 300 mg due to NDMA impurity and CGMP deviations. This event, originating from its Indian manufacturing facility, necessitates immediate action from procurement and regulatory teams to reassess supplier quality and ensure robust impurity control protocols.
Appco Pharma LLC initiated a Class II recall of Ranitidine Capsules 300 mg due to N-nitrosodimethylamine (NDMA) impurity in the API, stemming from CGMP deviations. This event, impacting 1,632 bottles distributed across the U.S., underscores critical supply chain vulnerabilities and the imperative for robust quality control and diversified sourcing strategies for procurement and regulatory teams.
Glenmark Pharmaceuticals Inc., USA initiated a nationwide Class II recall of over 1.3 million bottles of Ranitidine Tablets USP 300 mg due to CGMP deviations and NDMA impurity. This event underscores critical supply chain and quality control risks, demanding immediate action from procurement and regulatory teams to ensure product safety and supply continuity.