FDAFDA · Food and drugs·Recall number D-0878-2017
MAGNESIUM Sulfate added to 100 mL 0.9% Sodium Chloride injectable, 4g, Total Approximate Volume 108 mL (does not include mfg. overfill) Single Dose Container bag, Preservative Free, Rx Only, SCA Pharmaceuticals, 8821 Knoedl Ct. Little Rock, AR 72205, NDC: 70004-0737-32
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 # 20170509@29, Use By: 08/07/17
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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