FDAFDA · Food and drugs·Recall number D-0873-2017
fentaNYL (as citrate) in 0.9% Sodium Chloride injectable,10 mcg per mL, Total Volume 100 mL, Single Dose Container bag, (Total fentanyl Dose 1,000 mcg/100 mL) Preservative Free, Rx Only, SCA Pharmaceuticals, 8821 Knoedl Ct. Little Rock, AR 72205, NDC 70004-0202-32
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 # 20170506@14, Use By: 08/04/17
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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