FDA Drug Class III — Least Serious

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

Hazard

Subpotent Drug: Product has an an out of specification in iron assay analysis found during 18 month stability testing.

Products

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 N
Brand
West-Ward Pharmaceuticals Corp.
UPC
Lot #: 152032.1, Exp. Date. 2/2017

Units Affected

5,142 Shelf-packs