The Recall Desk
ModerateFDA (Drugs)·D-0190-2018·Announced 2018-01-17

KRS Global Biotechnology Recalls QUADMIX #17 Due to Expired Ingredients

KRS Global Biotechnology is recalling 122 vials of QUADMIX #17 because the product's beyond-use date exceeds the expiration date of at least one ingredient.

What this means for you

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 involves a labeling/expiration date discrepancy without reported illnesses or injuries, fitting the criteria for a moderate severity score.

Plain-English summary

KRS Global Biotechnology, Inc. is recalling 122 vials of QUADMIX #17, a prescription-only medication. The recall was initiated because the product's Beyond Use Date (BUD) exceeds the expiration date of at least one ingredient used to make the final product.

The affected product is identified by Lot 05242017@27 with a BUD of 11/20/2017. The recall covers distribution in the USA, Bermuda, and New Zealand.

Consumers and healthcare providers should stop using the affected vials and contact their healthcare provider or the manufacturer for further instructions.

The recalled product

Product
QUADMIX #17, 5 mL Vial, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd, Boca Raton, FL 33487.
Affected units
122

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@27 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 →