drugs Class II Updated 2012-08-22

Franck's Lab Inc., d.b.a. Franck's Compounding Lab recalls POVIDONE-IODINE OPHTHALMIC 5% SOLUTION 10 ML 125 ML 1

Recalled Product

POVIDONE-IODINE OPHTHALMIC 5% SOLUTION 10 ML 125 ML 15 ML 40 ML 50 ML; POVIDONE-IODINE, BUFFERED IN BSS 4.6% OPHTHALMIC 100 ML 120 ML 200 ML (8 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. 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: 0387489 0387820 0401069 0393386 0387489 0387489 0374184 0374184 0374184
View official government recall

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