FDAFDA · Food and drugs·Recall number D-0172-2017
SODIUM FERRIC GLUCONATE COMPLEX IN SUCROSE INJECTION, 62.5mg elemental iron/5mL, 10 (5mL vials) per shelf pack, Rx only, Mfd: Hikma Farmaceutica (Portugal,) SA Distributed by: Westward Eatowntown NJ 07724 USA, Shelf pack NDC 0143-9570-10, Unit dose NDC 0143-9570-01
Published December 14, 2016 · Recall initiated: November 17, 2016
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
Subpotent Drug: Product has an an out of specification in iron assay analysis found during 18 month stability testing.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Brand
- SODIUM FERRIC GLUCONATE COMPLEX IN SUCROSE
- Manufacturer
- West-Ward Pharmaceuticals Corp.
- Distributor
- US nationwide
- Lot
- Lot #: 152032.1, Exp. Date. 2/2017
- Risk classification
- Class III
- Area (FDA)
- drug
- Country
- United States
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