FDA-Drug2025-12-10Class IIPROCESSING DEFECT
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.
Hazard
cGMP deviations
Intended for
All ages
Illnesses reported
None reported
Sold states
USA Nationwide
Affected count
7920 bottles
Manufactured in
Plot No. 21/22 Bardez Blossom Pharmaceuticals Karaswada-Tivim, Bardej, Goa, India
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0209-2026Want us to check the next one for you?
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