Agency classClass IIOur severity:High FDA (Drugs)·D-1248-2022·Announced 2022-07-27

Injectable Lidocaine Syringes Recalled for Lack of Sterility Assurance

Nephron Sterile Compounding Center has recalled 1,380 prefilled lidocaine syringes nationwide due to inability to confirm product 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 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: FDA Class II recall of injectable medication with unconfirmed sterility. No illnesses reported, but non-sterile injectables carry direct risk of serious infection, meeting the rubric criterion of 'risk-of-harm products where injury has not yet been reported.'

Plain-English summary

Nephron Sterile Compounding Center LLC is recalling 1,380 prefilled syringes of 0.9% Buffered Lidocaine HCl injectable solution (9 mg/mL per 5 mL syringe). The affected product is lot BL2007A with an expiration date of July 3, 2022. This product was distributed nationwide in the United States.

The recall is due to lack of assurance of sterility. The manufacturer was unable to verify that the product met sterility requirements for injectable medications. Sterility is a critical requirement for any product intended for injection.

This is a Class II recall issued by the U.S. Food and Drug Administration. The risk associated with non-sterile injectable medications is serious infection. Healthcare providers and patients who may have received or been administered this product should be aware of the recall status.

The recalled product

Product: 0.9% Buffered Lidocaine HCl (buffered in 8.4% Sodium Bicarbonate), 45 mg/5 mL (9 mg/mL) syringes, packaged in 5 x 5 mL Prefilled Syringes per carton, 6 x 5 Syringe Carton per case, Rx Only, Nephron 503B outsourcing facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC…
Manufacturer: Nephron Sterile Compounding Center LLC
Category: Drug — Injectable Anesthetic
Hazard: lack-of-sterility
infection-risk
Affected units: 1,380

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 (2)

Lots: BL2007A
Exp. 7/3/2022

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 37 recalled by Nephron Sterile Compounding Center LLC 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 37 products in this recall →

Same manufacturer · Nephron Sterile Compounding Center LLC

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Same hazard · lack of sterility