FDAFDA · Food and drugs·Recall number D-1540-2012
HYDROMORPHONE P.F. 20MG/ML INTRATHECAL 40 ML; HYDROMORPHONE P.F. 25MG/ML INTRATHECAL 18 ML; HYDROMORPHONE P.F. 30MG/ML INTRATHECAL 18 ML; HYDROMORPHONE P.F. 50MG/ML INTRATHECAL 40 ML (4 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:N0393645 N0399634 N0398233 N0388437 N0395176 N0396644 N0403778 N0396442
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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