KRS Global Biotechnology Recalls Bacteriostatic Water for Injection Due to Sterility Concerns
KRS Global Biotechnology is recalling Bacteriostatic Water for Injection vials 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 poses a significant risk of serious injury or infection.
Plain-English summary
KRS Global Biotechnology, Inc. is recalling 6,568 vials of Bacteriostatic Water for Injection, 30 mL Vial, Rx Only (NDC 3321674177). The recall was initiated because the product lacks assurance of sterility.
The affected product was distributed nationwide. All lots remaining within their expiry dates are included in this recall.
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
- Bacteriostatic Water for Injection, 30 mL Vial, Rx Only, KRS Global Biotechnology791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321674177
- Manufacturer
- KRS Global Biotechnology, Inc
- Category
- Drug — Injectable
- Hazard
- Affected units
- 6,568
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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