FDA Drug Class II — Moderate

BORON 2MG/ML INJECTABLE 40 ML (2 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 because FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared.

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Products

BORON 2MG/ML INJECTABLE 40 ML (2 DIFFERENT PRODUCTS)
Brand
Franck's Lab Inc., d.b.a. Franck's Compounding Lab
UPC
Rx #'s: 0383013, 0383013

Units Affected

2 units

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