KRS Global Biotechnology Recalls Repinephrine IV Bags Due to Sterility Concerns
KRS Global Biotechnology is recalling 528 bags of Repinephrine in 0.9% Sodium Chloride due to a lack of assurance of sterility. The product was distributed nationwide.
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 recall is classified as FDA Class II, which corresponds to a Severe severity score (4) according to the rubric for significant injury or property damage reports, or high-risk situations.
Plain-English summary
KRS Global Biotechnology, Inc. is recalling 528 bags of NORepinephrine in 0.9% Sodium Chloride (PF), 250 mL IV bags. The specific product details include a concentration of 4 mg/250 mL (0.016 mg/mL) and the NDC 3321678032. The recall is being conducted because of a lack of assurance of sterility.
The affected product was distributed nationwide. The recall covers all lots remaining within their expiry dates. This is a prescription-only medication.
Consumers and healthcare providers should stop using the recalled product and contact their healthcare provider or the manufacturer for further instructions on how to return or dispose of the medication.
The recalled product
- Product
- NORepinephrine in 0.9% Sodium Chloride (PF), 250 mL IV bag, 4 mg/250 mL (0.016 mg/mL), Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487, NDC 3321678032
- Manufacturer
- KRS Global Biotechnology, Inc
- Category
- Drug — IV Infusion
- Hazard
- Affected units
- 528
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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