Drug 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.
D-0206-2026
Product summary
- Event
- Event 97935
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 912 containers
- Official record key
drug-enforcement:D-0206-2026
Official wording
Reason: cGMP deviations
Code information: Lot #: A352318
Distribution pattern: USA Nationwide
Derived failure modes
-
Manufacturing or process control
cGMP deviations