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Class II: temporary or reversible health riskTerminated

Edge Pharma Phenylephrine HCl 0 Recall

Phenylephrine HCl 0

Edge Pharma, LLC · Colchester, VT

Risk level
Class II
Reported by FDA
Feb 2, 2022
Recall ID
D-0415-2022
Check your lot numberHow we source this data

Summary

Edge Pharma recalled Phenylephrine HCl 0 starting Dec 6, 2021. The FDA classified it as Class II (temporary or reversible health risk) and published enforcement report D-0415-2022 on Feb 2, 2022. Reason: Lack of Assurance of Sterility. Status: Terminated.

Why it was recalled

Lack of Assurance of Sterility

Product description

Phenylephrine HCl 0.5 mg/5mL, (0.1 mg/mL), 5 mL per syringe, Single Use Syringe for IV Injection, Edge Pharma, LLC, 856 Hercules Dr, Colchester, VT 05446, NDC 05446-1545-05

Lot numbers, UPCs & expiration codes

09-2021-09@4 12/22/2021 & 10-2021-14@1 01/26/2022

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-0415-2022
Classification
Class II
Status
Terminated
Recall initiated
Dec 6, 2021
FDA report date
Feb 2, 2022
Quantity
3747 syringes
Recall type
Voluntary: Firm initiated
Recalling firm
Edge Pharma, LLC

Original FDA data

Every field from FDA enforcement report D-0415-2022, 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
09-2021-09@4 12/22/2021 & 10-2021-14@1 01/26/2022
Postal code
05446-8014
Report date
Feb 2, 2022
Product type
Drugs
Recall number
D-0415-2022
Classification
Class II
Recalling firm
Edge Pharma, LLC
Product quantity
3747 syringes
Termination date
Jun 7, 2023
Reason for recall
Lack of Assurance of Sterility
Voluntary / mandated
Voluntary: Firm initiated
Product description
Phenylephrine HCl 0.5 mg/5mL, (0.1 mg/mL), 5 mL per syringe, Single Use Syringe for IV Injection, Edge Pharma, LLC, 856 Hercules Dr, Colchester, VT 05446, NDC 05446-1545-05
Distribution pattern
nationwide
Recall initiation date
Dec 6, 2021
Initial firm notification
Press Release
Center classification date
Jan 24, 2022

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-0415-2022, published Feb 2, 2022. View the source record (openFDA) · FDA enforcement reports

Last checked against FDA data: . Content last changed: .

FindMyRecall is an independent service and is not affiliated with or endorsed by the FDA. This page simplifies the official record; the FDA or manufacturer notice is authoritative, so follow its instructions. Medication information here is not individualized medical advice.

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