FDAFDA · Food and drugs·Recall number D-1066-2014
The firm is recalling all lots of sterile products compounded by the pharmacy that are within expiry.
Published February 12, 2014 · Recall initiated: April 15, 2013
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: The recall is being initiated due to the lack of sterility assurance and concerns associated with the quality control processes identified during an FDA inspection.
What to do
Voluntary: Firm initiated · Press Release
Recall details
- Manufacturer
- Apothecure, Inc
- Distributor
- Nationwide
- Lot
- All Lots
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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