FDA Drug Class II — Moderate

MANNITOL 20% INJECTABLE 1250 ML 250 ML 2500 ML 400 ML; MANNITOL 25% INJECTABLE 1200 ML 300 ML 350 ML 400 ML 600 ML (9 DIFFERENT PRODUCTS)

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

MANNITOL 20% INJECTABLE 1250 ML 250 ML 2500 ML 400 ML; MANNITOL 25% INJECTABLE 1200 ML 300 ML 350 ML 400 ML 600 ML (9 DIFFERENT PRODUCTS)
Brand
Franck's Lab Inc., d.b.a. Franck's Compounding Lab
UPC
Rx #'s: 0391527 0391528 0393746 0391527 0391528 0393746 0403451 0404796 0397463 0402780 0402781 0402208 0396691 0402780

Units Affected

17 units