FDAFDA · Food and drugs·Recall number D-1305-2016
HYDROmorphone HCI 0.4mg/mL in 0.9% Sodium Chloride 25 mL fill in a 30 mL BD syringe;, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0815-67
Published July 20, 2016 · Recall initiated: April 20, 2016
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
What to do
Voluntary: Firm initiated · Press Release
Recall details
- Manufacturer
- Pharmakon Pharmaceuticals, Inc.
- Distributor
- Nationwide VA/DOD: CA, KY, MD, NC, OK, TX, VA
- Lot
- All Sterile Compounded Products within Expiry
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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