drugs Class II Updated 2012-08-22

Franck's Lab Inc., d.b.a. Franck's Compounding Lab recalls DMSO/VITAMIN C/GLUTATHIONE SOLUTION 6.25%/1.25%/1.25% OPHTHA

Recalled Product

DMSO/VITAMIN C/GLUTATHIONE SOLUTION 6.25%/1.25%/1.25% OPHTHALMIC 10 ML, 15 ML, 5 ML (3 DIFFERENT PRODUCTS)


Hazard / Issue

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 because FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: Rx #'s: 0393533 0387959 0366146 0395006 0401280 0408662
View official government recall

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