KRS Global Biotechnology Recalls Phenylephrine IV Bags Due to Sterility Concerns
KRS Global Biotechnology is recalling 708 bags of Phenylephrine HCl IV infusion due to a lack of assurance of sterility.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The agency classification is FDA Class II, and the hazard involves a lack of assurance of sterility in an IV infusion product, which poses a significant risk of serious injury or hospitalization if contaminated.
Plain-English summary
KRS Global Biotechnology, Inc. is recalling 708 bags of Phenylephrine HCl in 0.9% Sodium Chloride (PF) (Contains Sulfites), 25 mg / 250 mL (0.1 mg/mL), 250 mL Single-Dose Bag For IV Infusion Use. The product is identified by NDC 3321677861 and is distributed nationwide.
The recall was initiated due to a lack of assurance of sterility. The source text does not specify the exact cause of the sterility issue or provide details on specific lot numbers, stating only that all lots remaining within expiry are affected.
Healthcare providers and patients should stop using the affected product and contact the manufacturer or their supplier for further instructions. The source text does not report any specific illnesses or injuries associated with this recall.
The recalled product
- Product
- PHENYephrine HCl in 0.9% Sodium Chloride (PF) (Contains Sulfites), 25 mg / 250 mL (0.1 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 3321677861
- Manufacturer
- KRS Global Biotechnology, Inc
- Category
- Drug — IV Infusion
- Affected units
- 708
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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