KRS Global Biotechnology Recalls Estriol Cream Due to Expired Ingredient
KRS Global Biotechnology is recalling 300 jars of Estriol 0.1% Cream because the product's beyond-use date exceeds that 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, and the source text describes a labeling error regarding expiration dates without reporting any specific illnesses or injuries, fitting the criteria for a moderate severity score.
Plain-English summary
KRS Global Biotechnology, Inc. is recalling 300 jars of Estriol 0.1% (1 mg/gm) Cream, a prescription-only product. The recall is due to a labeling issue where the Beyond Use Date (BUD) of the final product exceeds the expiration date of at least one ingredient used in its manufacture.
The affected product is identified by Lot 07182017@45 with a Beyond Use Date of 1/14/2018. The product was distributed nationwide in the USA, as well as in Bermuda and New Zealand.
Consumers and healthcare providers should stop using the recalled product and contact their healthcare provider or the recalling firm for instructions on how to return or dispose of the medication.
The recalled product
- Product
- Estriol 0.1% (1 mg/gm) 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
- 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: 07182017@45 BUD: 1/14/2018
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.
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