FDAFDA · Food and drugs·Recall number D-1003-2017
MAGNESIUM Sulfate 4 g added to 100 mL 0.9% Sodium Chloride, Total Approximate Volume 108 mL (does not include mfg. overfill) Single Dose Container bag, Rx Only, SCA Pharmaceuticals, 8821 Knoedl Ct, Little Rock, AR 72205 (877) 550-5059; NDC: 70004-0737-32.
Published August 2, 2017 · Recall initiated: July 14, 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 made with recalled 0.9% sodium chloride bags which have the potential to leak.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- SCA Pharmaceuticals
- Distributor
- Nationwide in the USA
- Lot
- Lot: 20170710@54, BUD: 10/8/2017
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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