KRS Global Biotechnology Recalls Vitamin 9 Vials Due to Sterility Concerns
KRS Global Biotechnology is recalling 470 vials of Vitamin 9 Lyophilized for IM use nationwide because the product lacks 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 agency classification is FDA Class II, and the hazard involves a lack of assurance of sterility in an injectable product, which aligns with the rubric criteria for Severe severity (FDA Class II with potential for significant injury).
Plain-English summary
KRS Global Biotechnology, Inc. is recalling 470 vials of Vitamin 9 Lyophilized, Vial For IM Use. The product is prescription-only and was distributed nationwide. The recall is being conducted because the product lacks assurance of sterility.
The recall covers all lots remaining within their expiry date. The specific NDC for the product is 3321674147. No specific lot numbers or dates of distribution are provided in the source text.
Consumers and healthcare providers should stop using the affected product and contact their healthcare provider or the recalling firm for further instructions. The FDA has classified this recall as Class II.
The recalled product
- Product
- Vitamin 9 Lyophilized, Vial For IM Use, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321674147
- Manufacturer
- KRS Global Biotechnology, Inc
- Category
- Drug — Injectable Vitamin
- Affected units
- 470
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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