The Recall Desk
ModerateFDA (Drugs)·D-0447-2022·Announced 2022-02-02

Tetracaine HCl Nasal Solution Recalled for Manufacturing Deviations

Edge Pharma, LLC is recalling Tetracaine HCl Nasal Solution, 4%, due to Current Good Manufacturing Practice (CGMP) deviations. The recall affects 114 bottles distributed nationwide.

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 an FDA Class II recall for CGMP deviations. The source text does not report any illnesses, injuries, or deaths. The hazard is related to manufacturing process violations rather than a confirmed product defect or contamination event, making this a precautionary recall. Per the severity rubric, Class II recalls without reported harm typically warrant a score of 2 (Moderate).

Plain-English summary

Edge Pharma, LLC is recalling Tetracaine HCl Nasal Solution, 4%, 240 mL per bottle (NDC 05446-1195-03), a multiple-dose intranasal anesthetic product. The recall was initiated due to Current Good Manufacturing Practice (CGMP) deviations identified in the manufacturing process.

This is a voluntary recall initiated by the firm. The affected product was distributed nationwide. A total of 114 bottles are subject to this recall, with the following lot codes: 06-2021-08@5 (expiration 12-05-2021), 07-2021-07@7 (expiration 01-03-2022), 07-2021-27@10 (expiration 01-23-2022), and 10-2021-06@12 (expiration 04-04-2022).

Patients who have received this product should contact their healthcare provider or pharmacist. Healthcare providers should review the product with their patients and determine whether any corrective action is necessary. The recall has been terminated as of June 7, 2023.

The recalled product

Product
Tetracaine HCl Nasal Solution, 4%, 240 mL per bottle, Multiple Dose Container for Intranasal Use, Edge Pharma, LLC, 856 Hercules Dr., Colchester, VT, 05446, NDC 05446-1195-03, packaged in bottles.
Manufacturer
Edge Pharma, LLC
Category
Drug — Anesthetic / Nasal Solution
Hazard
  • cgmp-deviation
  • manufacturing-defect

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)

  • 06-2021-08@5 12-05-2021
  • 07-2021-07@7 01-03-2022
  • 07-2021-27@10 01-23-2022 & 10-2021-06@12 04-04-2022

Distribution

Distributed nationwide across the United States.

Related recalls

Same category