KRS Global Biotechnology Recalls Methylene Blue Injectable Vials for Labeling Errors
KRS Global Biotechnology is recalling 696 vials of Methylene Blue (PF) 10 mg/mL Injectable due to incorrect or missing lot and expiration dates.
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 involves a labeling error regarding expiration dates, which fits the rubric for minor labeling errors or low-risk contamination without reported injuries.
Plain-English summary
KRS Global Biotechnology, Inc. is recalling 696 vials of Methylene Blue (PF) 10 mg/mL (1%) Injectable Vial, Rx Only. The recall involves Lot 09252017@7 with a Beyond Use Date (BUD) of 12/24/2017. The product was distributed nationwide in the USA, Bermuda, and New Zealand.
The recall was initiated because of labeling errors where the Beyond Use Date (BUD) exceeded the BUD or expiration date of at least one ingredient used to make the final product. This discrepancy may result in incorrect or missing lot and expiration date information on the packaging.
Healthcare providers and patients who have this specific lot of Methylene Blue Injectable should stop using it and contact KRS Global Biotechnology, Inc. for further instructions or a return.
The recalled product
- Product
- Methylene Blue (PF) 10 mg/mL (1%) Injectable Vial, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd, Boca Raton, FL 33487.
- Manufacturer
- KRS Global Biotechnology, Inc
- Category
- Drug — Injectable
- Hazard
- Affected units
- 696
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: 09252017@7 BUD: 12/24/2017
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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