KRS Global Biotechnology Recalls Ketamine Syringes Due to Sterility Concerns
KRS Global Biotechnology is recalling 11,733 syringes of Ketamine in 0.9% Sodium Chloride 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 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 classified this as an FDA Class II recall. Per the rubric, FDA Class II recalls involving significant injury/property-damage reports or structural defects are rated Severe. While no injuries are reported, the lack of sterility assurance in a drug product is a significant hazard.
Plain-English summary
KRS Global Biotechnology, Inc. is recalling 11,733 syringes of Ketamine in 0.9% Sodium Chloride (PF) 50 mg/ 5mL (10 mg/mL). The product is a 5 mL fill in a 6 mL Single Dose Syringe, marked Rx Only, with NDC 3321678093.
The recall was initiated because of a lack of assurance of sterility. The source text does not specify the exact cause of the sterility issue or report any illnesses or injuries associated with the product.
The recalled product was distributed nationwide. All lots remaining within their expiry dates are affected. Healthcare providers and patients should stop using the product and contact the manufacturer or their supplier for further instructions.
The recalled product
- Product
- Ketamine in 0.9% Sodium Chloride (PF) 50 mg/ 5mL (10 mg/mL) 5 mL fill in a 6 mL Single Dose Syringe, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321678093
- Manufacturer
- KRS Global Biotechnology, Inc
- Category
- Drug — Injectable
- Hazard
- Affected units
- 11,733
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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