Sufentanil Citrate 0.4mcg/mL & Bupivacaine 0.1% in 0.9% Sodium Chloride 250 mL Intravia Bag, Rx ...
FDA Recall #D-1344-2016 — Class II — April 20, 2016
Product Description
Sufentanil Citrate 0.4mcg/mL & Bupivacaine 0.1% in 0.9% Sodium Chloride 250 mL Intravia Bag, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN, NDC 45183-0996-02
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
595
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