FDA Recalls Phenylephrine IV Bags Due to Sterility Concerns
KRS Global Biotechnology is recalling Phenylephrine HCl IV infusion bags because the company cannot ensure the product is sterile.
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 FDA classifies this recall as Class II. According to the rubric, an FDA Class II recall involving a structural defect or significant risk (such as lack of sterility in an IV product) corresponds to a severity score of 4 (Severe).
Plain-English summary
KRS Global Biotechnology, Inc. is recalling 60 bags of Phenylephrine HCl in 0.9% Sodium Chloride (PF) (Contains Sulfites), 30 mg/250 mL (0.12 mg/mL), 250 mL Single-Dose Bag For IV Infusion Use. The recall was initiated because the company lacks assurance of the product's sterility.
The affected product is identified by NDC 33216-7840-1. The recall covers all lots remaining within their expiration dates. The product was distributed nationwide.
Healthcare providers and patients should stop using the recalled product and contact KRS Global Biotechnology 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). 30 mg/250 mL (0.12 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 3321678401
- Manufacturer
- KRS Global Biotechnology, Inc
- Category
- Drug — IV Infusion
- Affected units
- 60
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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