FDA Drug Class II — Moderate

POVIDONE-IODINE/LIDOCAINE/TETRACAINE 4.6%/4%/0.5% OPHTHALMIC 30 ML (1 PRODUCT)

Hazard

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.

Products

POVIDONE-IODINE/LIDOCAINE/TETRACAINE 4.6%/4%/0.5% OPHTHALMIC 30 ML (1 PRODUCT)
Brand
Franck's Lab Inc., d.b.a. Franck's Compounding Lab
UPC
Rx #: 0410218

Units Affected

1 unit