Dexamethasone sodium phosphate, sterile otic solution for injection Preservative free, 19.2 mg/0.8mL (24mg/mL), 0.8 mL per syringe Single Use Syringe For Otic Injection, Edge Pharma LLC, 856 Hercules Dr., Colchester, VT 05446, NDC 05446-0848-01
Class I - DangerousWhat Should You Do?
- Check if you have this product: 09-2021-28@1 01/10/2022
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- Edge Pharma, LLC
- Reason for Recall:
- Lack of Assurance of Sterility
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
Dexamethasone sodium phosphate, sterile otic solution for injection Preservative free, 19.2 mg/0.8mL (24mg/mL), 0.8 mL per syringe Single Use Syringe For Otic Injection, Edge Pharma LLC, 856 Hercules Dr., Colchester, VT 05446, NDC 05446-0848-01
Product Codes/Lot Numbers:
09-2021-28@1 01/10/2022
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: D-0399-2022
Related Recalls
Class I - Dangerous
Lack of Assurance of Sterility.
Class I - Dangerous
Lack of Assurance of Sterility
Class I - Dangerous
Lack of Assurance of Sterility