HIGH

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...

cGMP deviations

Quick Facts at a Glance

Recall Date
October 31, 2025
Hazard Level
HIGH
Brands
NIVAGEN ZINC OXIDE, Nivagen Pharmaceuticals, Inc.
Geographic Scope
1 states

Hazard Information

cGMP deviations

What You Should Do

Consumers and healthcare providers should stop using this product immediately. Contact Blossom Pharmaceuticals or your healthcare provider for guidance. Notification method: Letter

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Full 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.. Generic: ZINC OXIDE; Brand: NIVAGEN ZINC OXIDE. Reason: cGMP deviations. Classification: Class II. Quantity: 912 containers. Distribution: USA Nationwide

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Product Classification

Product Details

Model Numbers
Lot #: A352318
UPC Codes
75834-170
75834-170-01
75834-170-02
+1 more
Affected States
ALL
Report Date
December 10, 2025
Source Agency
FDA - Drug Safety
Recall Status
ACTIVE

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