FDAFDA · Food and drugs·Recall number D-1531-2012
HEPARIN LOCK SODIUM*** (25X1ML) 100U/ML INJECTABLE 50 ML; HEPARIN LOCK SODIUM*** (25X5ML) 100U/ML INJECTABLE 125 MLS; HEPARIN SODIUM (25X30ML)** 1000U/ML(1MU/ML) INJECTABLE 120 ML, 60 ML, 90 ML; HEPARIN SODIUM **25X1ML 1000U/ML(1MU/ML INJECTABLE 25 ML, 50 ML (7 DIFFERENT PRODUCTS)
Published August 22, 2012 · Recall initiated: May 25, 2012
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the 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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Franck's Lab Inc., d.b.a. Franck's Compounding Lab
- Distributor
- Nationwide, Bahamas, Columbia, Dominican Republic, Grand Cayman, Guatemala, Poland, Santo Domingo, Venezuela, and West Indies
- Lot
- Rx #'s: 0387947 0391167 0394583 0394583 0394579 0390379 0390379
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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