Fagron Recalls Zinc Oxide Paste Due to Labeling Error
Fagron, Inc. is recalling Zinc Oxide Paste 25% because of an incorrect strength value in the Drug Facts Panel.
The agency’s classification
FDA (Drugs): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
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 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The recall is classified as FDA Class III and involves a minor labeling error where the correct strength is still visible on the primary container, posing no significant health risk.
Plain-English summary
Fagron, Inc. is recalling Zinc Oxide Paste 25%, 500 g, intended for prescription compounding. The recall is due to a labeling error where the Drug Facts Panel displays an incorrect strength value, although the correct strength is displayed on the primary container.
The affected product is identified by Lot # 17C01-U07-036096 and has an expiration date of 5/1/2020. The product was distributed nationwide within the US.
Consumers and healthcare providers should stop using the affected product and contact Fagron, Inc. for further instructions or a replacement.
The recalled product
- Product
- Zinc Oxide Paste 25%, 500 g, For Prescription Compounding, Fagron Inc.2400 Pilot Knob Rd, St. Paul, MN 55120m NDC 51522-0694-5.
- Manufacturer
- Fagron, Inc
- Category
- Drug — Compounding Ingredient
- Hazard
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 (2)
- Lot #: 17C01-U07-036096
- Exp. 5/1/2020
Distribution
Distributed nationwide across the United States.
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