KRS Global Biotechnology Recalls QUADMIX #16 Due to Labeling Errors
KRS Global Biotechnology is recalling 126 vials of QUADMIX #16 because the 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, which typically involves a situation where use of, or exposure to, a violative product 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 a moderate severity recall.
Plain-English summary
KRS Global Biotechnology, Inc. is recalling 126 vials of QUADMIX #16, a prescription-only medication. The product is a 5 mL vial manufactured by KRS Global Biotechnology, Inc., located in Boca Raton, Florida.
The recall was initiated due to a labeling error where the Beyond Use Date (BUD) exceeds the expiration date of at least one ingredient used to make the final product. The affected lot number is 05242017@25, with a BUD of 11/20/2017.
The product was distributed nationwide in the USA, Bermuda, and New Zealand. Consumers and healthcare providers should stop using the affected product and contact the manufacturer for further instructions.
The recalled product
- Product
- QUADMIX #16, 5 mL Vial, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd, Boca Raton, FL 33487.
- Manufacturer
- KRS Global Biotechnology, Inc
- Category
- Drug — Biologic
- Hazard
- Affected units
- 126
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@25 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.
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