Perrigo Recalls Nystatin Powder for Labeling Error on Declared Strength
Perrigo Company PLC is recalling Nystatin, USP Powder for Rx compounding due to a labeling error regarding the declared strength.
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: The recall is classified as FDA Class II and involves a minor labeling error regarding declared strength, which fits the rubric criteria for moderate severity.
Plain-English summary
Perrigo Company PLC is recalling Nystatin, USP Powder for Rx compounding, 50 Million Units, due to a labeling error on the declared strength. The affected product is identified by NDC 0574-0405-05 and UPC 305740404058.
The recall involves 948 units of the product, specifically Lot # 2015050194 with an expiration date of 2/2016. The product was distributed nationwide.
Consumers and healthcare providers should check their inventory for this specific lot and NDC number. If found, the product should be returned to the supplier or disposed of according to local regulations.
The recalled product
- Product
- Nystatin, USP Powder for Rx compounding, 50 Million Units, Packaged by Perrigo, Minneapolis MN 55427, NDC 0574-0405-05, UPC 305740404058.
- Manufacturer
- Perrigo Company PLC
- Category
- Drug — Pharmaceutical Powder
- Hazard
- Affected units
- 948
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 #: 2015050194
- Exp 2/2016
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 recalled by Perrigo Company PLC 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.
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