KRS Global Biotechnology Recalls Repinephrine IV Bags Due to Sterility Concerns
KRS Global Biotechnology is recalling 1,464 bags of Repinephrine in 0.9% Sodium Chloride 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 recall is classified as FDA Class II and involves a lack of assurance of sterility in an intravenous product, which poses a significant risk of serious injury or death if contaminated.
Plain-English summary
KRS Global Biotechnology, Inc. is recalling 1,464 bags of Repinephrine in 0.9% Sodium Chloride (PF), 250 mL IV bags. The product is identified by NDC 3321678406 and is available in all lots remaining within their expiry dates. The recall was initiated because of a lack of assurance of sterility.
The affected product was distributed nationwide. The recall is classified as Class II by the U.S. Food and Drug Administration. No specific dates of distribution or specific facilities affected are listed in the source text.
Healthcare providers and consumers should stop using the recalled product and contact KRS Global Biotechnology for further instructions or a refund.
The recalled product
- Product
- NORepinephrine in 0.9% Sodium Chloride (PF), 250 mL IV bag, 8 mg/250 mL (0.032 mg/mL),Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321678406
- Manufacturer
- KRS Global Biotechnology, Inc
- Category
- Drug — IV Solution
- Affected units
- 1,464
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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