Fentanyl Citrate 25 mcg/mL in 0.9% Sodium Chloride 25 mL in 30 mL syringe, Rx Only, Compounded by...
FDA Recall #D-1286-2016 — Class II — April 20, 2016
Product Description
Fentanyl Citrate 25 mcg/mL in 0.9% Sodium Chloride 25 mL in 30 mL syringe, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0521-67
Reason for Recall
Lack of Assurance of Sterility
Recalling Firm
Pharmakon Pharmaceuticals, Inc. — Noblesville, IN
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Drugs
Product Quantity
20
Distribution
Nationwide VA/DOD: CA, KY, MD, NC, OK, TX, VA
Code Information
All Sterile Compounded Products within Expiry
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated