KRS Global Biotechnology Recalls Lidocaine and Epinephrine Syringes for Sterility Concerns
KRS Global Biotechnology is recalling 4,105 syringes of Lidocaine and Epinephrine 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 recall is classified as FDA Class II and involves a lack of assurance of sterility in a medical product, which poses a significant risk of infection or serious injury.
Plain-English summary
KRS Global Biotechnology, Inc. is recalling 4,105 syringes of Lidocaine HCl 0.75% / Epinephrine 0.025% in BSS. The product is distributed in 1 mL fill in 3 mL single-dose syringes and is available by prescription only. The recall was initiated because of a lack of assurance of sterility.
The affected product is identified by NDC 3321678395. The recall covers all lots remaining within their expiry dates. The product was distributed nationwide.
Consumers and healthcare providers should stop using the recalled syringes and contact their healthcare provider or the manufacturer for further instructions.
The recalled product
- Product
- LIDOcaine HCl 0.75%(7.5 mg/mL)/ EPINRPHrine 0.025% (0.25 mg/mL) (PF) (Sulfite Free) in BSS, 1 mL Fill in a 3 mL Single Dose Syringe, Rx only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321678395
- Manufacturer
- KRS Global Biotechnology, Inc
- Category
- Drug — Injectable Anesthetic
- Affected units
- 4,105
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.
See all 80 products in this recall →Related recalls
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