FDA Drug Class II — Moderate

TAURINE 50MG/ML INJECTABLE 120 ML 30 ML 40 ML 60 ML (4 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

TAURINE 50MG/ML INJECTABLE 120 ML 30 ML 40 ML 60 ML (4 DIFFERENT PRODUCTS)
Brand
Franck's Lab Inc., d.b.a. Franck's Compounding Lab
UPC
Rx #'s: 0374591 0374591 0391633 0391633 0374591

Units Affected

11 units