Nivagen zinc oxide ointment, 1 ounce bottles, recalled over manufacturing deviations
Blossom Pharmaceuticals is recalling 7,920 bottles of Nivagen Zinc Oxide Ointment USP 20%, 1 oz, over current good manufacturing practice deviations.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: Scored 2 because the record cites current good manufacturing practice deviations with no stated product defect or reported harm.
Plain-English summary
Nivagen Zinc Oxide Ointment USP, Zinc Oxide 20%, net weight 1 oz (28.4g), made in India and from Nivagen Pharmaceuticals, Inc. of Sacramento, California, under NDC 75834-170-02, is being recalled.
The reason given in the enforcement record is cGMP deviations.
The recall covers 7,920 bottles from lot A352505. Distribution was nationwide in the USA. The FDA has classified the action as Class II.
The record cites manufacturing practice deviations without describing a specific product defect, and states no injuries. Customers should follow the firm's instructions.
The recalled product
- Product
- NIVAGEN ZINC OXIDE (ZINC OXIDE)
- Brand
- NIVAGEN ZINC OXIDE
- Manufacturer
- Blossom Pharmaceuticals
- Category
- Drug — Skin protectant
- Affected units
- 7,920
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Lot #: A352505
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 13 recalled by Blossom Pharmaceuticals under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 13 products in this recall →Related recalls
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