drugs Class II Updated 2012-08-22

Franck's Lab Inc., d.b.a. Franck's Compounding Lab recalls ENGERIX-B, SDV** 20MCG/ML INJECTABLE 1 ML (1 PRODUCT)

Recalled Product

ENGERIX-B, SDV** 20MCG/ML INJECTABLE 1 ML (1 PRODUCT)

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 #: 0410015
View official government recall

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