Isovue 200 mg/mL PF and 300 mg/mL PF, Vials, manufactured by New England Compounding Center, Fram...
FDA Recall #D-119-2013 — Class II — September 26, 2012
Product Description
Isovue 200 mg/mL PF and 300 mg/mL PF, 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
7055 vials
Distribution
Nationwide
Code Information
All lot codes
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated