KRS Global Biotechnology Recalls Vitamin 5 B Vials Due to Sterility Concerns
KRS Global Biotechnology is recalling 616 vials of Vitamin 5 B for IM use because the company cannot ensure the product is sterile.
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 recall is classified as FDA Class II and involves a lack of assurance of sterility in an injectable product, which poses a significant risk of serious injury or infection, fitting the 'Severe' criteria for significant injury reports or high-risk defects.
Plain-English summary
KRS Global Biotechnology, Inc. is recalling 616 vials of Vitamin 5 B, 30 mL Vial For IM Use, Rx Only (NDC 3321674253). The recall is being conducted because the company lacks assurance of the sterility of the product. The affected lots are all remaining within their expiry dates.
The product was distributed nationwide. The recall is classified as Class II by the U.S. Food and Drug Administration. No specific illnesses or injuries are reported in the source text.
Healthcare providers and patients should stop using the affected product and contact the recalling firm for further instructions or a refund.
The recalled product
- Product
- Vitamin 5 B, 30 mL Vial For IM Use, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321674253
- Manufacturer
- KRS Global Biotechnology, Inc
- Category
- Drug — Injectable Vitamin
- Affected units
- 616
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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