Phenylephrine HCl, Sterile Solution for Injection, (PF), 800 mcg/10mL (80 mcg/mL), Single Use Syringe for IV Injection, Edge Pharma, LLC 856 Hercules Dr., Colchester, VT 05446, NDC 05446-1652-01

Class I - Dangerous
💊 Drugs Recalled: December 6, 2021 Edge Pharma Prescription Drugs Nationwide

What Should You Do?

  1. Check if you have this product:
    08-2021-27@4 12/09/2021, 09-2021-17@1 12/30/2021, 10-2021-15@1 01/27/2022 & 10-2021-28@1 02/09/2022
  2. Do not eat it: Even if it looks and smells fine, do not consume this product.
  3. Throw it away or return it: You can return the product to the store for a full refund.
  4. Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
  5. 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:

Phenylephrine HCl, Sterile Solution for Injection, (PF), 800 mcg/10mL (80 mcg/mL), Single Use Syringe for IV Injection, Edge Pharma, LLC 856 Hercules Dr., Colchester, VT 05446, NDC 05446-1652-01

Product Codes/Lot Numbers:

08-2021-27@4 12/09/2021, 09-2021-17@1 12/30/2021, 10-2021-15@1 01/27/2022 & 10-2021-28@1 02/09/2022

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: D-0417-2022

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