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Class II: temporary or reversible health riskTerminated

Edge Pharma Vitamin K Recall

Vitamin K (Vitamin K ) Oral Solution (PF), 5 mg/mL, 1mL per syringe, single Dose Syring…

Edge Pharma, LLC · Colchester, VT

Risk level
Class II
Reported by FDA
Feb 2, 2022
Recall ID
D-0445-2022
Check your lot numberHow we source this data

Summary

Edge Pharma recalled Vitamin K starting Dec 6, 2021. The FDA classified it as Class II (temporary or reversible health risk) and published enforcement report D-0445-2022 on Feb 2, 2022. Reason: CGMP Deviations. Status: Terminated.

Why it was recalled

CGMP Deviations

Product description

Vitamin K (Vitamin K ) Oral Solution (PF), 5 mg/mL, 1mL per syringe, single Dose Syringe for Oral Use, Edge Pharma, LLC, 856 Hercules Dr., Colchester, VT 05446, NDC 05446-1132-03

Lot numbers, UPCs & expiration codes

10-2021-11@6 01-09-2022 10/27/21 - 11/16/21 11-2021-01@8 01-30-2022 11/16/21 - 12/01/21

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-0445-2022
Classification
Class II
Status
Terminated
Recall initiated
Dec 6, 2021
FDA report date
Feb 2, 2022
Quantity
757 syringes
Recall type
Voluntary: Firm initiated
Recalling firm
Edge Pharma, LLC

Original FDA data

Every field from FDA enforcement report D-0445-2022, 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
10-2021-11@6 01-09-2022 10/27/21 - 11/16/21 11-2021-01@8 01-30-2022 11/16/21 - 12/01/21
Postal code
05446-8014
Report date
Feb 2, 2022
Product type
Drugs
Recall number
D-0445-2022
Classification
Class II
Recalling firm
Edge Pharma, LLC
Product quantity
757 syringes
Termination date
Jun 7, 2023
Reason for recall
CGMP Deviations
Voluntary / mandated
Voluntary: Firm initiated
Product description
Vitamin K (Vitamin K ) Oral Solution (PF), 5 mg/mL, 1mL per syringe, single Dose Syringe for Oral Use, Edge Pharma, LLC, 856 Hercules Dr., Colchester, VT 05446, NDC 05446-1132-03
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-0445-2022, 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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