The Recall Desk
ModerateFDA (Drugs)·D-0444-2022·Announced 2022-02-02

Lidocaine HCl/Phenylephrine HCl Nasal Solution Recalled for CGMP Deviations

Edge Pharma, LLC is recalling Lidocaine HCl/Phenylephrine HCl Nasal Solution (4%/1%) nationwide due to Current Good Manufacturing Practice (CGMP) deviations. The recall involves 231 bottles.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: This is a Class II recall from the FDA involving manufacturing practice deviations. No illnesses, injuries, or deaths are reported in the source text, and the hazard is regulatory/manufacturing-based rather than from confirmed product contamination or defect. Per the rubric, FDA Class II without hospitalization or injury reports is typically Moderate (score 2).

Plain-English summary

Edge Pharma, LLC is voluntarily recalling Lidocaine HCl/Phenylephrine HCl Nasal Solution, 4%/1%, 240 mL per bottle, in multiple-dose containers, due to Current Good Manufacturing Practice (CGMP) deviations. The product is identified by NDC 05446-1045-03 and was manufactured by Edge Pharma, LLC in Colchester, Vermont.

The recall affects 231 bottles that were distributed nationwide. The affected product lot codes and dates are: 07-2021-02@7 (distributed 12-29-2021), 07-2021-23@4 (distributed 01-19-2022), 08-2021-11@7 (distributed 02-07-2022), 08-2021-23@8 (distributed 02-19-2022), and 09-2021-24@10 (distributed 03-23-2022).

Consumers who have purchased this product should stop using it and contact their healthcare provider or pharmacist for guidance. The recall was initiated by the firm on December 6, 2021, and was classified as Class II by the FDA on January 24, 2022.

The recalled product

Product
Lidocaine HCl/Phenylephrine HCl Nasal Solution, 4%/1%, 240 mL per bottle, Multiple Dose Container, Edge Pharma, LLC 856 Hercules Dr., Colchester, VT 05446, NDC 05446-1045-03
Manufacturer
Edge Pharma, LLC
Category
Drug — Nasal Solution
Hazard
  • cgmp-deviation

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 (4)

  • 07-2021-02@7 12-29-2021
  • 07-2021-23@4 01-19-2022
  • 08-2021-11@7 02-07-2022
  • 08-2021-23@8 02-19-2022 & 09-2021-24@10 03-23-2022

Distribution

Distributed nationwide across the United States.

Related recalls

Same category