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Class II: temporary or reversible health riskTerminated

Pharmakon Pharmaceuticals Fentanyl Citrate 25mcg/mL in 0 Recall

Fentanyl Citrate 25mcg/mL in 0

Pharmakon Pharmaceuticals, Inc. · Noblesville, IN

Risk level
Class II
Reported by FDA
Jul 20, 2016
Recall ID
D-1291-2016
Check your lot numberHow we source this data

Summary

Pharmakon Pharmaceuticals recalled Fentanyl Citrate 25mcg/mL in 0 starting Apr 20, 2016. The FDA classified it as Class II (temporary or reversible health risk) and published enforcement report D-1291-2016 on Jul 20, 2016. Reason: Lack of Assurance of Sterility. Status: Terminated.

Why it was recalled

Lack of Assurance of Sterility

Product description

Fentanyl Citrate 25mcg/mL in 0.9% Sodium Chloride 30 mL fill in a 35 mL Monoject Plungerless Syringe, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0683-68

Lot numbers, UPCs & expiration codes

All Sterile Compounded Products within Expiry

Where it was sold

Nationwide VA/DOD: CA, KY, MD, NC, OK, TX, VA

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-1291-2016
Classification
Class II
Status
Terminated
Recall initiated
Apr 20, 2016
FDA report date
Jul 20, 2016
Quantity
5
Recall type
Voluntary: Firm initiated
Recalling firm
Pharmakon Pharmaceuticals, Inc.

Original FDA data

Every field from FDA enforcement report D-1291-2016, exactly as published.

Show all FDA fields
City
Noblesville
State
IN
Status
Terminated
Country
United States
Event ID
73960
Address
14450 Getz Rd
Code information
All Sterile Compounded Products within Expiry
Postal code
46060-3303
Report date
Jul 20, 2016
Product type
Drugs
Recall number
D-1291-2016
Classification
Class II
Recalling firm
Pharmakon Pharmaceuticals, Inc.
Product quantity
5
Termination date
Jan 11, 2018
Reason for recall
Lack of Assurance of Sterility
Voluntary / mandated
Voluntary: Firm initiated
Product description
Fentanyl Citrate 25mcg/mL in 0.9% Sodium Chloride 30 mL fill in a 35 mL Monoject Plungerless Syringe, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0683-68
Distribution pattern
Nationwide VA/DOD: CA, KY, MD, NC, OK, TX, VA
Recall initiation date
Apr 20, 2016
Initial firm notification
Press Release
Center classification date
Jul 11, 2016

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-1291-2016, published Jul 20, 2016. View the source record (openFDA) · FDA enforcement reports

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

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