Epinephrine HCI 5 mcg/mL in 0.9% Sodium Chloride, 10mL syringe, Rx Only, Compounded by PHARMAKON ...
FDA Recall #D-1301-2016 — Class II — April 20, 2016
Product Description
Epinephrine HCI 5 mcg/mL in 0.9% Sodium Chloride, 10mL syringe, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0800-72
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
1200
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