KRS Global Biotechnology Recalls Oxytocin IV Bags Due to Sterility Concerns
KRS Global Biotechnology is recalling Oxytocin IV bags because the company cannot guarantee 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 recall is classified as FDA Class II, which corresponds to a 'Severe' rating under the rubric, particularly given the risk of infection associated with non-sterile IV products.
Plain-English summary
KRS Global Biotechnology, Inc. is recalling Oxytocin in 0.9% Sodium Chloride Solution (PF), 30 Units / 500 mL (0.06 Units / mL) Single Dose IV Bags. The recall is being conducted because the company lacks assurance of the sterility of the product.
The recall involves 4,497 bags of the medication, identified by NDC 3321676819. The affected product was distributed nationwide. The recall includes all lots remaining within their expiration dates.
Healthcare providers and patients should stop using the recalled product and contact their healthcare provider for further instructions. Consumers should not use the product if they have it in their possession.
The recalled product
- Product
- OxyTOCIN in 0.9% Sodium Chloride Solution (PF), 30 Units / 500 mL (0.06 Units / mL) Single Dose IV Bag, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321676819
- Manufacturer
- KRS Global Biotechnology, Inc
- Category
- Drug — IV Solution
- Hazard
- Affected units
- 4,497
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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