FDAFDA · Food and drugs·Recall number D-0438-2022
Lidocaine HCl / Oxymetazoline HCl Nasal Solution, 4% / 0.05%, 240mL per bottle, Multiple Dose Container for Intranasal Use, Edge Pharma, LLC, 856 Hercules Dr., Colchester, VT 05446, NDC 05446-1256-01, packaged in bottles. no label
Published February 2, 2022 · Recall initiated: December 6, 2021
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
CGMP Deviations
What to do
Voluntary: Firm initiated · Press Release
Recall details
- Manufacturer
- Edge Pharma, LLC
- Distributor
- nationwide
- Lot
- 06-2021-18@3 12-15-2021 07/07/21 - 07/22/21 06-2021-30@10 12-27-2021 07/20/21 - 08/17/21 07-2021-14@4 01-10-2022 08/05/21 - 08/20/21 07-2021-21@4 01-17-2022 08/23/21 - 09/16/21, 07-2021-28@9 01-24-2022 09/13/21 - 10/05/21 08-2021-12@8 02-08-2022 10/01/21 - 10/19/21 08-2021-24@9 02-20-2022 10/19/21 - 11/11/21 09-2021-09@10 03-08-2022 11/10/21 - 11/30/21 10-2021-05@6 04-03-2022 11/30/21
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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