The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Drugs)·D-0652-2016·Announced 2016-02-10

Perrigo Recalls Nystatin Powder for Labeling Error on Declared Strength

Perrigo is recalling 918 units of Nystatin USP Powder due to a labeling error regarding the declared strength. The product was distributed nationwide.

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 labeling error on declared strength, which fits the rubric for minor labeling errors or low-risk contamination.

Plain-English summary

Perrigo Company PLC is recalling 918 units of Nystatin, USP Powder for Rx compounding, 150 Million Units. The recall is due to a labeling error on the declared strength of the product. The affected lot number is 2015080484, with an expiration date of 02/2016.

The product was distributed nationwide. The NDC is 0574-0404-15 and the UPC is 305740404157. The recall is classified as Class II by the FDA.

Consumers and healthcare providers should check their inventory for this specific lot and stop using the product if it matches the description. They should contact their supplier or the recalling firm for further instructions on disposal or return.

The recalled product

Product
Nystatin, USP Powder for Rx compounding, 150 Million Units, Packaged by Perrigo, Minneapolis MN 55427, NDC 0574-0404-15, UPC 305740404157
Manufacturer
Perrigo Company PLC
Category
Drug — Antifungal Powder
Hazard
Affected units
918

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 #: 2015080484
  • Exp 02/2016

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.

See all 2 products in this recall →

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