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

Plain-English summary

Franck's Lab Inc., d.b.a. Franck's Compounding Lab, is recalling 47 units of sterile human drugs, specifically various formulations of glutathione in inhalation and injectable forms. The recall covers products distributed nationwide and in several international locations, including the Bahamas, Colombia, Dominican Republic, Grand Cayman, Guatemala, Poland, Santo Domingo, Venezuela, and the West Indies, between November 21, 2011, and May 21, 2012.

The recall was initiated because FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where these sterile products were prepared. This lack of assurance of sterility poses a risk to patients who use these injectable or inhalation medications.

Consumers and healthcare providers should stop using the affected products immediately. The specific prescription numbers associated with the recalled units are listed in the official recall documentation. Patients should contact their healthcare provider for alternative treatment options.

The recalled product

Product

GLUTATHIONE INHALATION 30MG/ML SOLUTION 120 ML, 60 ML; GLUTATHIONE P.F. 200MG/ML INJECTABLE 10 ML, 100 ML, 14 ML, 150 ML, 175 ML, 20 ML, 30 ML, 300 ML, 40 ML, 40 MLS, 50 ML, 58 MLS, 70 ML; GLUTATHIONE P.F. 50MG/ML (500MG/10ML) INJECTABLE 100 ML, 150 ML, 20 ML, 40 ML, 60 ML;

Manufacturer

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

Category

Drug — Sterile Injectable/Inhalation

Hazard

• microbial-contamination
• fungal-growth
• infection-risk

Affected units

47

Distribution

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