The Recall Desk
SevereFDA (Drugs)·D-0413-2022·Announced 2022-02-02

Phenol Injection Solution Recall Due to Lack of Sterility Assurance

Edge Pharma, LLC is recalling Phenol Sterile Solution for Injection (6%, 5 mL vials) nationwide due to lack of assurance of sterility. The recall affects 309 vials distributed under specific lot codes.

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: This recall is FDA Class II for a sterile injectable pharmaceutical with a direct risk of serious infection from non-sterile injection near nerves. Although no illness or injury is reported in the source text, the agency's Class II classification for a parenteral product with sterility failure meets the threshold for Severe (score 4) per the rubric criterion requiring FDA Class II recalls to score at least 4.

Plain-English summary

Edge Pharma, LLC is recalling Phenol, Sterile Solution for Injection (PF), 6%, 5 mL per vial for single-use perineural injection due to lack of assurance of sterility. The product is manufactured by Edge Pharma, LLC, located at 856 Hercules Drive, Colchester, Vermont 05446, with NDC 05446-1476-05.

A total of 309 vials have been recalled and were distributed nationwide. The affected lot codes are 09-2021-14@5 (dated 12/29/2021), 10/21/21, and 11-2021-04@2 (dated 02/15/2022).

Phenol is injected directly around nerves for medical purposes. A lack of sterility assurance in an injectable product raises the risk of infection at the injection site. Patients who have received this product should consult their healthcare provider if they develop signs of infection.

The FDA classified this as a Class II recall. Consumers and healthcare providers with questions or concerns should contact Edge Pharma, LLC or the FDA's drug safety information line.

The recalled product

Product
Phenol, Sterile Solution for Injection (PF), 6%, 5 mL per vial, Single Use Vial for Perineural Injection, Edge Pharma, LLC, 856 Hercules Dr., Colchester, VT 05446, NDC 05446-1476-05, packaged in vials.
Manufacturer
Edge Pharma, LLC
Category
Drug — Injectable / Pharmaceutical
Hazard
  • sterility-failure
  • 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 (3)

  • 09-2021-14@5 12/29/2021
  • 10/21/21 & 11-2021-04@2
  • 02/15/2022

Distribution

Distributed nationwide across the United States.

Related recalls

Same category