Product: Nivagen Pharmaceuticals, Zinc Oxide Ointment USP, Zinc Oxide 20% Skin Protectant, Net Wt. 15 oz (425g), Made in India, Manufactured for: Nivagen Pharmaceuticals, Inc., Sacramento, CA 95827, USA, NDC 75834-170-15.
Reason for recall: cGMP deviations
Recall initiated: 20251031
Status: Ongoing
Classification: Class II
Recall type: Voluntary: Firm initiated