KRS Global Biotechnology Recalls Vitamin 9A/B Lyophilized Vials Due to Sterility Concerns
KRS Global Biotechnology is recalling 6,325 vials of Vitamin 9A/B Lyophilized for IM use due to a lack of assurance of sterility.
What this means for you
Illness, injury, or structural failure has been reported. 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 criteria for Severe severity (FDA Class II with potential for significant injury).
Plain-English summary
KRS Global Biotechnology, Inc. is recalling 6,325 vials of Vitamin 9A/B Lyophilized, Vial For IM Use, Rx Only (NDC 3321678339). The recall was initiated because of a lack of assurance of sterility for the product.
The affected product is distributed nationwide. The recall includes all lots remaining within their expiry dates. The product is a prescription-only medication intended for intramuscular use.
Consumers and healthcare providers should stop using the affected product and contact their healthcare provider or the recalling firm for further instructions.
The recalled product
- Product
- Vitamin 9A/B Lyophilized, Vial For IM Use, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321678339
- Manufacturer
- KRS Global Biotechnology, Inc
- Category
- Drug — Injectable Vitamin
- Hazard
- Affected units
- 6,325
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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