drugs Class II Updated 2012-08-22

Franck's Lab Inc., d.b.a. Franck's Compounding Lab recalls DICLOFENAC SODIUM, SDPF - (0.1ML SYRINGE, 30G, 1/2") 500MCG/

Recalled Product

DICLOFENAC SODIUM, SDPF - (0.1ML SYRINGE, 30G, 1/2") 500MCG/0.1ML INJECTABLE 0.5 ML, 2 ML, 4 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: 0392224 0378833 0402369 0360916 0402369
View official government recall

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