KRS Global Biotechnology Recalls Repinephrine IV Bags Due to Labeling Error
KRS Global Biotechnology is recalling 190 bags of Repinephrine 16 mg IV solution due to a label mix-up. The product was distributed nationwide.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II due to a labeling error (label mix-up). Per the rubric, minor labeling errors without reported injuries or illnesses fall under the Moderate severity category.
Plain-English summary
KRS Global Biotechnology, Inc. is recalling 190 bags of Repinephrine 16 mg added to 0.9% Sodium Chloride (PF), 16 mg / 250 mL, 250 mL IV bag. The recall was initiated due to a labeling error, specifically a label mix-up. The affected product is identified by Lot 12112018@24 with an expiration date of 01/25/2019 and NDC 3321678343.
The FDA has classified this recall as Class II. The product was distributed nationwide in the USA. No specific illnesses or injuries are reported in the source text.
Healthcare providers and patients should discontinue use of the affected product and contact their healthcare provider for further instructions. Consumers should check their medication for the specific lot number and expiration date listed above.
The recalled product
- Product
- NORepinephrine 16 mg added to 0.9% Sodium Chloride (PF), 16 mg / 250 mL, 250 mL IV bag, Rx only, KRS Global Biotechnology: 791 Park of Commerce Blvd., Boca Raton, FL 33487. NDC 3321678343
- Manufacturer
- KRS Global Biotechnology, Inc
- Category
- Drug — IV Solution
- Hazard
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)
- Lot: 12112018@24 Exp. 01/25/2019
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 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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