D-0206-2026 Class II Ongoing
Recall Details
- Product Type
- Drugs
- Report Date
- December 10, 2025
- Initiation Date
- October 31, 2025
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 912 containers
Product Description
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
Distribution Pattern
USA Nationwide
Code Information
Lot #: A352318