The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Drugs)·D-0168-2018·Announced 2018-01-17

FDA Recalls Bi-Est Cream Due to Expired Ingredient Dates

KRS Global Biotechnology is recalling 300 jars of Bi-Est 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, but the source text identifies the issue as a labeling error regarding expiration dates without reporting any illnesses or injuries, fitting the criteria for a moderate severity voluntary precautionary recall.

Plain-English summary

The U.S. Food and Drug Administration (FDA) has issued a Class II recall for Bi-Est (Estriol/Estradiol) (80/20) + Progesterone 7.5 mg/200 mg Cream. The recall involves 300 jars of the prescription-only medication manufactured by KRS Global Biotechnology, Inc. The specific lot affected is 08172017@39, with a Beyond Use Date (BUD) of 12/15/2017.

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 contain ingredients that are past their expiration dates, which could affect the safety or efficacy of the medication.

The affected product was distributed nationwide in the USA, as well as in Bermuda and New Zealand. Consumers who have this specific lot of Bi-Est Cream should stop using it and contact their healthcare provider or pharmacist for guidance on disposal or replacement.

The recalled product

Product
Bi-Est (Estriol/Estradiol) (80/20) + Progesterone 7.5 mg/200 mg 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 Hormone 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: 08172017@39 BUD: 12/15/2017

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 →

Related recalls

Same manufacturer · KRS Global Biotechnology, Inc

See all →

Same hazard · mis labeling

See all →

Similar recalls