West-Ward Pharmaceuticals Corp. recalls SODIUM FERRIC GLUCONATE COMPLEX IN SUCROSE INJECTION, 62.5mg elemental iron/5mL, 10 (5mL vials) per shelf pack, Rx only,
Recalled December 14, 2016 · FDA recall D-0172-2017 · West-Ward Pharmaceuticals
Hazard
Subpotent Drug: Product has an an out of specification in iron assay analysis found during 18 month stability testing. · FDA Class III
Units
5,142 Shelf-packs
Sold at
US nationwide
Description
Subpotent Drug: Product has an an out of specification in iron assay analysis found during 18 month stability testing.
Product
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
Manufacturer(s)
West-Ward Pharmaceuticals Corp.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →