KRS Global Biotechnology Recalls Vitamin 10 B Vials Due to Sterility Concerns
KRS Global Biotechnology is recalling 6,747 vials of Vitamin 10 B Lyophilized for IM use nationwide 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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II and involves a risk-of-harm product (sterility issue in an injectable drug) where injury has not yet been reported, meeting the criteria for a High severity score.
Plain-English summary
KRS Global Biotechnology, Inc. is recalling 6,747 vials of Vitamin 10 B Lyophilized, For IM Use, Rx Only (NDC 3321678338). The recall is being conducted because of a lack of assurance of sterility in the product.
The affected product was distributed nationwide. The recall includes all lots remaining within their expiration dates. The product is intended for intramuscular (IM) use and is prescription-only.
Consumers and healthcare providers should stop using the recalled product and contact their healthcare provider or the manufacturer for further instructions.
The recalled product
- Product
- Vitamin 10 B Lyophilized, Vial, For IM Use, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC3321678338
- Manufacturer
- KRS Global Biotechnology, Inc
- Category
- Drug — Injectable Vitamin
- Affected units
- 6,747
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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