Omnipaque 240mg/mL PF, 300mg/mL PF, in 3 mL, 5 mL, and 10 mL, vials, manufactured by New England ...
FDA Recall #D-122-2013 — Class II — September 26, 2012
Product Description
Omnipaque 240mg/mL PF, 300mg/mL PF, in 3 mL, 5 mL, and 10 mL, vials, manufactured by New England Compounding Center, Framingham, MA
Reason for Recall
Lack of Assurance of Sterility
Recalling Firm
New England Compounding Center — Framingham, MA
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Drugs
Product Quantity
8919 vials
Distribution
Nationwide
Code Information
All lot codes
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated