NIVAGEN ZINC OXIDE

Blossom Pharmaceuticals has initiated a Class II recall of 912 containers of Zinc Oxide Ointment USP, manufactured for Nivagen Pharmaceuticals, Inc., due to cGMP deviations at its Bardej, Goa, India facility. This nationwide USA recall underscores critical quality control lapses, demanding immediate assessment by procurement and regulatory teams. Decision-makers must evaluate supply chain vulnerabilities and enhance due diligence for contract manufacturing partners, particularly those in India.

Nivagen Pharmaceuticals faces a Class II recall for 7,920 bottles of Zinc Oxide Ointment USP distributed nationwide. Initiated by Blossom Pharmaceuticals due to cGMP deviations at an Indian facility, this event signals critical quality control lapses. Procurement and regulatory teams must reassess supplier qualification and supply chain resilience for topical drug ingredients from the region.