Oxytocin 20 Units added to Lactated Ringers in a 1000 mL lntravia bag, Rx Only, Compounded by PHA...
FDA Recall #D-1299-2016 — Class II — April 20, 2016
Product Description
Oxytocin 20 Units added to Lactated Ringers in a 1000 mL lntravia bag, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0769-04
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
384
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