Saline 10% and 3%, in 5 mL and 10 mL vials, manufactured by New England Compounding Center, Frami...
FDA Recall #D-123-2013 — Class II — September 26, 2012
Product Description
Saline 10% and 3%, in 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
54 vials
Distribution
Nationwide
Code Information
All lot codes
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated