Hyaluronidase 150 u/ml PF, 1 mL, 5 mL, and 10 mL vials, manufactured by New England Compounding C...
FDA Recall #D-118-2013 — Class II — September 26, 2012
Product Description
Hyaluronidase 150 u/ml PF, 1 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
10,865 vials
Distribution
Nationwide
Code Information
All lot codes
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated