FDA Drug Class II — Moderate

LIDOCAINE/SODIUM BICARBONATE/HEPARIN IRRIGATION 10.6MG/16.8MG/2667U/ML SOLUTIO 90 ML (1 PRODUCT)

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. 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

LIDOCAINE/SODIUM BICARBONATE/HEPARIN IRRIGATION 10.6MG/16.8MG/2667U/ML SOLUTIO 90 ML (1 PRODUCT)
Brand
Franck's Lab Inc., d.b.a. Franck's Compounding Lab
UPC
Rx #: 0394097

Units Affected

1 unit

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