The Recall Desk
SevereFDA (Drugs)·D-0395-2022·Announced 2022-02-02

Lidocaine HCl Sterile Buffered Solution Recalled for Lack of Sterility Assurance

Edge Pharma is recalling Lidocaine HCl Sterile Buffered Solution for Injection (1%, 10 mL syringes) due to lack of assurance of sterility. The recall affects approximately 4,465 syringes distributed nationwide.

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 FDA classified this as a Class II recall. The hazard—lack of sterility assurance in an injectable medication—poses a significant risk of serious infection (including sepsis), which is a serious adverse health consequence. Although no hospitalization reports are mentioned in the source, the inherent risk of infection from non-sterile injectables, combined with FDA Class II designation, justifies a Severe rating.

Plain-English summary

Edge Pharma, LLC is recalling Lidocaine HCl Sterile Buffered Solution for Injection (PF) 1%, 10 mL per syringe, Single Use Syringe for Infiltration and Nerve Block, NDC 05446-0850-10, due to lack of assurance of sterility.

The recalled syringes were distributed nationwide. Affected lots are identified by codes 08-2021-27@3 (12/09/2021), 09-2021-24@1 (01/06/2022), and 10-2021-14@2 (01/31/2022). A total of approximately 4,465 syringes are affected.

Lidocaine HCl is an injectable anesthetic used for infiltration and nerve block procedures. Use of a non-sterile injectable product could result in serious infection. Consumers and healthcare providers who have received or used product from the affected lots should stop use immediately. Healthcare facilities should check their inventory and quarantine affected product.

The recalled product

Product
Lidocaine HCl Sterile Buffered Solution for Injection (PF) 1%, 10mL per syringe, Single Use Syringe for Infiltration and Nerve Block, Edge Pharma, LLC, 856 Hercules Dr., Colchester, VT 05446, NDC 05446-0850-10
Manufacturer
Edge Pharma, LLC
Category
Drug — Injectable / Anesthetic
Hazard
  • sterility-assurance
  • infection-risk
  • injectable-contamination

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)

  • 08-2021-27@3 12/09/2021 09-2021-24@1 01/06/2022 10-2021-14@2 01/31/2022

Distribution

Distributed nationwide across the United States.

Related recalls

Same category