Why it was recalled
CGMP Deviations
Product description
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
Lot numbers, UPCs & expiration codes
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
Where it was sold
nationwide
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0438-2022
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Dec 6, 2021
- FDA report date
- Feb 2, 2022
- Quantity
- 386 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Edge Pharma, LLC
Original FDA data
Every field from FDA enforcement report D-0438-2022, exactly as published.
Show all FDA fields
- City
- Colchester
- State
- VT
- Status
- Terminated
- Country
- United States
- Event ID
- 89172
- Address
- 856 Hercules Dr
- Code information
- 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
- Postal code
- 05446-8014
- Report date
- Feb 2, 2022
- Product type
- Drugs
- Recall number
- D-0438-2022
- Classification
- Class II
- Recalling firm
- Edge Pharma, LLC
- Product quantity
- 386 bottles
- Termination date
- Jun 7, 2023
- Reason for recall
- CGMP Deviations
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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
- Distribution pattern
- nationwide
- Recall initiation date
- Dec 6, 2021
- Initial firm notification
- Press Release
- Center classification date
- Jan 24, 2022