KRS Global Biotechnology Recalls Lidocaine HCl Syringes Due to Sterility Concerns
KRS Global Biotechnology is recalling Lidocaine HCl 2% syringes nationwide due to a lack of assurance of sterility. The recall affects 4,450 syringes.
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, which poses a risk of serious injury or death from infection, meeting the criteria for a Severe rating.
Plain-English summary
KRS Global Biotechnology, Inc. is recalling Lidocaine HCl 2% (PF) 100 mg/5 mL (20 mg/mL) 5 mL Fill in a 6 mL Single Dose Syringes. The recall is being conducted because of a lack of assurance of sterility. The product is prescription-only and is identified by NDC 3321678315.
The recall involves 4,450 syringes distributed nationwide. All lots remaining within their expiry date are affected. The agency has classified this recall as Class II.
Consumers and healthcare providers should stop using the affected syringes and contact their healthcare provider or the recalling firm for further instructions.
The recalled product
- Product
- LIDOcaine HCl 2% (PF) 100 mg/5 mL (20 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 33487NDC 3321678315
- Manufacturer
- KRS Global Biotechnology, Inc
- Category
- Drug — Injectable
- Affected units
- 4,450
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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