The Recall Desk
HighFDA (Drugs)·D-1264-2022·Announced 2022-07-27

Lidocaine HCl injection syringes recalled due to sterility assurance failure

Nephron Sterile Compounding Center has recalled 37,310 syringes of Lidocaine HCl Injection USP 1% nationwide due to lack of assurance of sterility. Affected lots expire between August and October 2022.

What this means for you

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: This is an FDA Class II recall of an injectable medication where sterility assurance could not be verified. No hospitalizations or illnesses have been reported. Per the severity rubric, a risk-of-harm product without reported injury is classified as High (3).

Plain-English summary

Nephron Sterile Compounding Center LLC is recalling Lidocaine HCl Injection, USP 1%, in pre-filled 5 mL syringes (10 mg/mL) nationwide. The recall encompasses 37,310 syringes due to lack of assurance of sterility.

The affected product includes syringes from four lots: LI2004A (expiration 8/6/2022), LI2005A (expiration 8/31/2022), LI2006A (expiration 9/21/2022), and LI2008A (expiration 10/11/2022). Lidocaine is a local anesthetic used in medical and dental procedures. The FDA classified this as a Class II recall. The lack of sterility assurance means that the FDA could not verify that the product remained sterile during manufacturing or storage, creating a potential health risk.

Healthcare facilities and pharmacies should stop using and distributing the affected product immediately. Patients who may have received injections from the recalled lots should contact their healthcare provider with any health concerns.

The recalled product

Product
Lidocaine HCl Injection, USP 1%, 50 mg/5 mL (10 mg/mL) syringe, packaged in 5 x 5 mL Pre-Filled 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: 69374-985-05
Manufacturer
Nephron Sterile Compounding Center LLC
Category
Drug — Injectable medication
Hazard
  • sterility-failure

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 (8)

  • Lots: LI2004A
  • Exp. 8/6/2022
  • LI2005A
  • Exp. 8/31/2022
  • LI2006A
  • Exp. 9.21.2022
  • LI2008A
  • Exp. 10/11/2022

Distribution

Distributed nationwide across the United States.

Related recalls

Same category