FDAFDA · Food and drugs·Recall number D-0986-2017
Potassium PHOSphate in 0.9% Sodium Chloride Injection, 10 mMol in a) 100 mL in 150 mL Intravia Bag (NDC 61553-288-48) Service Code: 2K5288, and b) 250 mL in 250 mL Intravia Bag (NDC 61553-281-11) Service Code: 2K5281, Rx Only, PharMEDium Services, LLC 12620 W. Airport Blvd #130 Sugar Land, TX 77478 800-523-7749
Published July 26, 2017 · Recall initiated: June 26, 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; media fill failure at manufacturer
What to do
Voluntary: Firm initiated · Press Release
Recall details
- Manufacturer
- PharMedium Services, Llc
- Distributor
- Nationwide
- Lot
- Lots: a) 171280006S Exp. 8/6/2017; 171280125S Exp. 8/7/2017; 171290006S Exp. 8/7/2017; 171290028D Exp. 8/8/2017; 171360002S Exp. 8/15/2017; b) 171280011S Exp. 8/7/2017
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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