LIDOCAINE/SODIUM BICARBONATE/HEPARIN IRRIGATION 10.6MG/16.8MG/2667U/ML SOLUTIO 90 ML (1 PRODUCT)
Recall Number: D-1562-2012
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
Reason for Recall
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.
Product Description
LIDOCAINE/SODIUM BICARBONATE/HEPARIN IRRIGATION 10.6MG/16.8MG/2667U/ML SOLUTIO 90 ML (1 PRODUCT)