FDAFDA · Food and drugs·Recall number D-0625-2016
HYDROMORPHONE HCL, Packaged as a) 2.5MG in 1ML Syringes, b) 150MG in 75ML Homepumps, c) 125MG in 125ML Homepumps, d) 250MG in 125ML Homepumps, e) 135MG in 135ML Homepumps, Rx Only. SENTARA HOME HEALTH SENTARA RX, 535 Independence Pkwy ste.300, Chesapeake, VA 23320-5176.
Published February 3, 2016 · Recall initiated: September 18, 2015
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: Product sterility cannot be guaranteed.
What to do
Voluntary: Firm initiated · E-Mail
Recall details
- Manufacturer
- Sentara Enterprises
- Distributor
- U.S. Including: VA, NC
- Lot
- All Lots compounded between 11-Sep-15 and 17-Sep-15. Expiries: a) 29-Sep-15 b) 30-Sep-15 c) 1-Oct-15, d) 30-Sep-15, e) 30-Sep-15
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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