The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Drugs)·D-0164-2018·Announced 2018-01-17

KRS Global Biotechnology Recalls Topical Cream Due to Expired Ingredient

KRS Global Biotechnology is recalling 490 jars of Arginine/Lysine/Glutamine Topical Cream 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 due to a labeling/expiration date discrepancy where the product's BUD exceeds an ingredient's expiration date. This is a minor labeling error with no reported illnesses, fitting the 'Moderate' severity criteria for low-risk contamination or labeling issues.

Plain-English summary

KRS Global Biotechnology, Inc. is recalling 490 jars of Arginine 150 mg/ Lysine HCl 50 mg/ Glutamine 200 mg/g Topical Cream. The product is a prescription-only topical cream packaged in jars. The recall was initiated because the Beyond Use Date (BUD) of the final product exceeds the expiration date of at least one ingredient used to make it.

The affected product is identified by Lot 05242017@54 and has a Beyond Use Date of 11/20/2017. The recall covers distribution in the USA, Bermuda, and New Zealand. The FDA has classified this recall as Class II, indicating that use of or exposure to the product might cause temporary or medically reversible adverse health consequences.

Consumers and healthcare providers should stop using the affected product and contact their healthcare provider or the recalling firm for instructions on return or disposal. No specific illnesses or injuries have been reported in the source text.

The recalled product

Product
Arginine 150 mg/ Lysine HCl 50 mg/ Glutamine 200 mg/g 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
490

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: 05242017@54 BUD: 11/20/2017

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 →

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