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

Plain-English summary

Franck's Lab Inc., d.b.a. Franck's Compounding Lab, has initiated a recall of all sterile human drugs distributed between November 21, 2011, and May 21, 2012. The recall covers 529 units of various alprostadil injectable and gel products, including specific concentrations and volumes, as well as combination products with papaverine and phentolamine.

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 of infection to patients who receive these injections.

The affected products were distributed nationwide as well as to the Bahamas, Columbia, Dominican Republic, Grand Cayman, Guatemala, Poland, Santo Domingo, Venezuela, and the West Indies. Patients and healthcare providers should stop using the recalled products and contact their healthcare provider for guidance on alternative treatments.

The recalled product

Product

ALPROSTADIL 10MCG/ML INJECTABLE 10 ML, 20 ML, 3 ML, 30 ML, 5 ML, 6 ML; ALPROSTADIL 15MCG/ML INJECTABLE 5 ML; ALPROSTADIL 20MCG/ML INJECTABLE 10 ML, 10 MLS, 20 ML, 3 ML, 30 ML, 4 ML, 40 ML, 5 ML, 6 ML; ALPROSTADIL 24MCG/ML INJECTABLE 6 ML; ALPROSTADIL 25MCG/ML INJECTABLE 10 M

Manufacturer

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

Category

Drug — Sterile Injectable

Hazard

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

Affected units

529

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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