FDAFDA · Food and drugs·Recall number D-0875-2017
HYDROmorphone HCL in 0.9% Sodium Chloride injectable, 0.2 mg per ml, Total Volume 100mL, Single Dose Container bag, (Total HYDROmorphone Dose 20 mg per 100 mL) Preservative Free, Rx Only, SCA Pharmaceuticals, 8821 Knoedl Ct. Little Rock, AR 72205, NDC 70004-0300-55
Published June 7, 2017 · Recall initiated: May 18, 2017
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 bags leaking at seam.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- SCA Pharmaceuticals
- Distributor
- Nationwide in the USA
- Lot
- LOT # 20170505@23, 20170505@28, Use By: 08/03/17
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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