KRS Global Biotechnology Recalls Lidocaine and Hyaluronidase Syringes for Sterility Concerns
KRS Global Biotechnology is recalling Lidocaine HCl and Hyaluronidase syringes due to a lack of assurance of sterility. The recall covers 2,615 syringes distributed nationwide.
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, which corresponds to a Severe severity score under the rubric for drug recalls involving potential health risks without reported fatalities.
Plain-English summary
KRS Global Biotechnology, Inc. is recalling Lidocaine HCl 30 mg/mL/Hyaluronidase 15 Units/mL (PF) 5 mL Fill in a 6 mL Single Dose Syringes. The recall is being conducted because of a lack of assurance of sterility. The affected product is prescription-only and is identified by NDC 3321678368.
The recall involves 2,615 syringes. The distribution pattern is nationwide, and the recall covers all lots remaining within their expiry dates. The source text does not specify specific lot numbers or expiration dates.
Consumers and healthcare providers should stop using the affected syringes and contact their healthcare provider or the recalling firm for further instructions. The source text does not report any illnesses or injuries associated with this recall.
The recalled product
- Product
- Lidocaine HCl 30 mg/mL/Hyaluronidase 15 Units/mL (PF) 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 3321678368
- Manufacturer
- KRS Global Biotechnology, Inc
- Category
- Drug — Injectable
- Hazard
- Affected units
- 2,615
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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