TRIMIX/LIDOCAINE 11.8MG/0.39MG/10.6MCG/1.7MG/ML INJECTABLE 30 ML; TRIMIX/LIDOCAINE 13.6MG/0.45MG/38.2MCG/7.3MG/ML INJECTABLE 10 ML; TRIMIX/LIDOCAINE 12MG/1MG/5MCG/1%/ML INJECTABLE 10 MLS; TRIMIX/LIDOCAINE 17.65MG/0.59MG/5.9MCG/2% INJECTABLE 10 ML (4 DIFFERENT PRODUCTS)

Recall Number: D-1630-2012

Firm: Franck's Lab Inc., d.b.a. Franck's Compounding Lab

Classification: Class II

Status: Terminated

Report Date: 20120822

Initiation Date: 20120521

Termination Date: 20140815

Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012. FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared.

TRIMIX/LIDOCAINE 11.8MG/0.39MG/10.6MCG/1.7MG/ML INJECTABLE 30 ML; TRIMIX/LIDOCAINE 13.6MG/0.45MG/38.2MCG/7.3MG/ML INJECTABLE 10 ML; TRIMIX/LIDOCAINE 12MG/1MG/5MCG/1%/ML INJECTABLE 10 MLS; TRIMIX/LIDOCAINE 17.65MG/0.59MG/5.9MCG/2% INJECTABLE 10 ML (4 DIFFERENT PRODUCTS)