D-121-2013 Class II Terminated

Recalled by New England Compounding Center — Framingham, MA

FDA drug recall D-121-2013 was initiated by New England Compounding Center on September 26, 2012 and is designated Class II. Reason for recall: Lack of Assurance of Sterility The recall status is terminated (terminated October 7, 2016). Affected quantity: 3,321 vials.

Recall Details

Product Type
Drugs
Report Date
January 9, 2013
Initiation Date
September 26, 2012
Termination Date
October 7, 2016
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
3,321 vials

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

Distribution Pattern

Nationwide

Code Information

All lot codes