FDAClass IIJuly 20, 2016

Fentanyl Citrate 10mcg/mL in 0.9% Sodium Chloride recall: Sterility Concern

Fentanyl Citrate 10mcg/mL in 0.9% Sodium Chloride, 50mL Cadd Cassette (grey), Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060…

Why was Fentanyl Citrate 10mcg/mL in 0.9% Sodium Chloride recalled?

Lack of Assurance of Sterility

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

All Sterile Compounded Products within Expiry

Product
Fentanyl Citrate 10mcg/mL in 0.9% Sodium Chloride, 50mL Cadd Cassette (grey), Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060…
Recalling firm
Pharmakon Pharmaceuticals, Inc.
Quantity
5
Distribution
Nationwide VA/DOD: CA, KY, MD, NC, OK, TX, VA
Recall date
July 20, 2016
Classification
Class II
Status
Terminated
Agency
FDA (drug)
Open FDA enforcement record Latest recalls