Recalls / Class II
Class IID-0438-2022
Product
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
- Affected lot / code info
- 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
Why it was recalled
CGMP Deviations
Recalling firm
- Firm
- Edge Pharma, LLC
- Notification channel
- Press Release
- Type
- Voluntary: Firm initiated
- Address
- 856 Hercules Dr, Colchester, Vermont 05446-8014
Distribution
- Quantity
- 386 bottles
- Distribution pattern
- nationwide
Timeline
- Recall initiated
- 2021-12-06
- FDA classified
- 2022-01-24
- Posted by FDA
- 2022-02-02
- Terminated
- 2023-06-07
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0438-2022. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.