KRS Global Biotechnology Recalls Phenylephrine IV Bags Due to Sterility Concerns
KRS Global Biotechnology is recalling 228 bags of Phenylephrine HCl IV infusion 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. According to the rubric, FDA Class II recalls with potential for significant injury or hospitalization (implied by sterility failure in IV products) are rated as Severe (4).
Plain-English summary
KRS Global Biotechnology, Inc. is recalling 228 bags of Phenylephrine HCl in 0.9% Sodium Chloride (PF) (Contains Sulfites), 100 mg / 250 mL (0.4 mg/mL), 250 mL Single-Dose Bag For IV Infusion Use. The recall is being conducted because of a lack of assurance of sterility for the product.
The affected product is identified by NDC 3321678039. The recall covers all lots remaining within their expiry dates. The product was distributed nationwide.
Healthcare providers and patients should stop using the recalled product and contact their healthcare provider for further instructions. The FDA classifies this recall as Class II, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- PHENYephrine HCl in 0.9% Sodium Chloride (PF) (Contains Sulfites), 100 mg / 250 mL (0.4 mg/mL), 250 mL Single-Dose Bag For IV Infusion Use, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321678039
- Manufacturer
- KRS Global Biotechnology, Inc
- Category
- Drug — IV Infusion
- Hazard
- Affected units
- 228
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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