Drug product
Nivagen, Zinc Oxide Ointment USP, Zinc Oxide 20 %, Net Wt. 1 oz. (28.4g), Nivagen Pharmaceuticals, Inc., Sacramento, CA 95827, USA, Made in India, NDC 75834-170-02.
D-0209-2026
Product summary
- Event
- Event 97935
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 7920 bottles
- Official record key
drug-enforcement:D-0209-2026
Official wording
Reason: cGMP deviations
Code information: Lot #: A352505
Distribution pattern: USA Nationwide
Derived failure modes
-
Manufacturing or process control
cGMP deviations