The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Drugs)·D-0188-2018·Announced 2018-01-17

KRS Global Biotechnology Recalls Progesterone 3% Topical Cream Due to Labeling Errors

KRS Global Biotechnology is recalling 300 jars of Progesterone 3% Topical Cream because the 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 that may cause temporary or medically reversible adverse health consequences. The specific issue is a labeling error regarding the expiration date, which fits the criteria for moderate severity involving minor labeling errors or low-risk contamination.

Plain-English summary

KRS Global Biotechnology, Inc. is recalling 300 jars of Progesterone 3% Topical Cream, a prescription-only medication. The product was distributed nationwide in the USA, Bermuda, and New Zealand. The specific lot affected is 09212017@22, with a Beyond Use Date (BUD) of March 20, 2018.

The recall was initiated due to a labeling error where the 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 not be stable or effective for the entire duration listed on the label.

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

The recalled product

Product
Progesterone 3% Topical Cream packaged in jars, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd, Boca Raton, FL 33487.
Manufacturer
KRS Global Biotechnology, Inc
Category
Drug — Topical Cream
Hazard
Affected units
300

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: 09212017@22 BUD: 3/20/2018

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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