Lidocaine 1% PF, 2% PF, and 4% PF, in 1 mL, 2 mL, 5 mL, and 10 mL vials, manufactured by New Engl...

FDA Recall #D-121-2013 — Class II — September 26, 2012

Recall #D-121-2013 Date: September 26, 2012 Classification: Class II Status: Terminated

Product Description

Lidocaine 1% PF, 2% PF, and 4% PF, in 1 mL, 2 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

3,321 vials

Distribution

Nationwide

Code Information

All lot codes

Status

Terminated

Voluntary / Mandated

Voluntary: Firm initiated