KRS Global Biotechnology Recalls IV Vitamin B12 Vials for Sterility Concerns
KRS Global Biotechnology is recalling 948 vials of IV Vitamin B12 products due to a lack of assurance of sterility. The recall is 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 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 948 vials of Vitamin B1/B2/B3/B6/HYDROXOCOBALAMIN 66/1.33/66/66/0.66 mg/mL (PF), For IV Use, 3 mL fill in a 5 mL Single Dose Vial. The recall is being conducted because of a lack of assurance of sterility. The affected product is prescription-only and is identified by NDC 3321678335.
The recall covers all lots remaining within their expiry dates. The product was distributed nationwide. The agency has classified this recall as Class II.
Healthcare providers and patients should stop using the affected product and contact the manufacturer or their supplier for further instructions. Consumers should not use the recalled product.
The recalled product
- Product
- Vitamin B1/B2/B3/B6/HYDROXOCOBALAMIN 66/1.33/66/66/0.66 mg/mL (PF), For IV Use, 3 mL fill in a 5 mL Single Dose Vial, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321678335
- Manufacturer
- KRS Global Biotechnology, Inc
- Category
- Drug — Intravenous Vitamin
- Affected units
- 948
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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