The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Drugs)·D-0192-2018·Announced 2018-01-17

FDA Recalls Savinase Topical Solution Due to Expired Ingredient Labeling

KRS Global Biotechnology is recalling Savinase 100 mcg/mL Topical Solution because the product's beyond-use date exceeds the expiration date of at least one ingredient.

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, which typically involves a situation where use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences. The hazard is a labeling error regarding expiration dates, which is a moderate risk.

Plain-English summary

The U.S. Food and Drug Administration (FDA) has issued a recall for Savinase 100 mcg/mL Topical Solution, 1 mL in a 3 mL Droptainer, manufactured by KRS Global Biotechnology, Inc. The recall involves 30 droptainers from Lot 06262017@31, which has a beyond-use date (BUD) of 6/26/2018.

The recall was initiated due to a labeling error where the product's beyond-use date exceeds the expiration date of at least one ingredient used to make the final product. This discrepancy indicates that the product may contain ingredients that are past their expiration dates, potentially affecting the product's stability or efficacy.

The affected product was distributed nationwide in the USA, Bermuda, and New Zealand. Consumers and healthcare providers should stop using the recalled product and contact their healthcare provider or the manufacturer for further instructions.

The recalled product

Product
Savinase 100 mcg/mL Topical Solution, 1 mL in a 3 mL Droptainer, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd, Boca Raton, FL 33487.
Manufacturer
KRS Global Biotechnology, Inc
Category
Drug — Topical Solution
Hazard
Affected units
30

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: 06262017@31 BUD: 6/26/2018

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 47 recalled by KRS Global Biotechnology, Inc 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 47 products in this recall →

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