KRS Global Biotechnology Recalls Lidocaine HCl Syringes Due to Sterility Concerns
KRS Global Biotechnology is recalling Lidocaine HCl 1% syringes because the company cannot guarantee 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. According to the rubric, FDA Class II recalls with potential for adverse health consequences (such as lack of sterility in injectable drugs) are categorized as Severe (Score 4), as they are not Class I but involve significant risk.
Plain-English summary
KRS Global Biotechnology, Inc. is recalling Lidocaine HCl 1% (PF) 50 mg/5 mL single-dose syringes. The recall is being conducted because the company lacks assurance of the sterility of the product. The affected product is identified by NDC 3321678424 and includes all lots remaining within their expiry dates.
The recall involves 2,565 syringes that were distributed nationwide. The product is prescription-only. The source text does not specify a particular lot number or expiration date, indicating that all remaining stock within the expiry period is affected.
Consumers and healthcare providers should stop using the recalled syringes and contact their healthcare provider or the recalling firm for further instructions. The FDA has classified this recall as Class II, indicating a situation where use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- LIDOcaine HCl 1% (PF) 50 mg/5 mL (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 3321678424
- Manufacturer
- KRS Global Biotechnology, Inc
- Category
- Drug — Injectable
- Affected units
- 2,565
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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