D-0209-2026 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
- 7920 bottles
Product Description
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.
Reason for Recall
cGMP deviations
Distribution Pattern
USA Nationwide
Code Information
Lot #: A352505