Franck's Lab Recalls Sterile Injectable Drugs Due to Microbial Contamination

Plain-English summary

Franck's Lab Inc., d.b.a. Franck's Compounding Lab, is recalling all sterile human drugs distributed between November 21, 2011, and May 21, 2012. The recall was initiated due to a lack of assurance of sterility. FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where these sterile products were prepared.

The affected products include Iopamidol 41% Injectable in various volumes (198 ml, 99 ml, 50 ml, 600 ml, 72 ml) and Iohexol Injectable in 4 ml vials (240 mg iodine/ml) and 3 ml vials (300 mg iodine/ml) in various volumes (200 ml, 180 ml, 600 ml, 90 ml, 900 ml). The recall covers 3 units of these products.

These products were distributed nationwide as well as in the Bahamas, Columbia, Dominican Republic, Grand Cayman, Guatemala, Poland, Santo Domingo, Venezuela, and the West Indies. Consumers and healthcare providers should stop using these products and contact the recalling firm or their healthcare provider for further instructions.

The recalled product

Product

IOPAMIDOL 41% INJECTABLE 198 ML 99 ML 50 ML 600 ML 72 ML; IOHEXOL, 4ML VIAL 240MG IODINE/ML INJECTABLE 200 ML; IOHEXOL, 3ML VIAL 300MG IODINE/ML INJECTABLE 180 ML 600 ML 90 ML 900 ML (2 DIFFERENT PRODUCTS)

Manufacturer

Franck's Lab Inc., d.b.a. Franck's Compounding Lab

Category

Drug — Injectable Sterile Drugs

Hazard

• microbial-contamination
• fungal-growth

Affected units

3

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Distribution

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