FDA Recalls Fentanyl IV Bags Due to Sterility Concerns
KRS Global Biotechnology is recalling 492 bags of fentanyl IV solution nationwide due to a lack of assurance of sterility.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II, which indicates a situation where use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences. The hazard of sterility failure in an IV product poses a significant risk of infection.
Plain-English summary
The U.S. Food and Drug Administration (FDA) has issued a Class II recall for fentaNYL Citrate in 0.9% Sodium Chloride (PF) 1,000 mcg/100 mL (10 mcg/mL) 100 mL Fill in 150 mL IV Bag. The product is manufactured by KRS Global Biotechnology, Inc. The recall involves 492 bags distributed nationwide.
The recall was initiated due to a lack of assurance of sterility. This means the manufacturer cannot guarantee that the product is free from microbial contamination. The recall covers all lots remaining within their expiry dates.
Healthcare providers and patients should stop using the affected product immediately. The FDA advises that this is a prescription-only medication. Users should contact their healthcare provider for guidance on alternative treatments or further instructions.
The recalled product
- Product
- fentaNYL Citrate in 0.9% Sodium Chloride (PF) 1,000 mcg/100 mL (10 mcg/mL) 100 mL Fill in 150 mL IV Bag, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 33216282300
- Manufacturer
- KRS Global Biotechnology, Inc
- Category
- Drug — IV Solution
- Affected units
- 492
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)
- All lots remaining within expiry.
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 80 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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