FDA-Drug2016-12-14Class III
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
West-Ward Pharmaceuticals Corp.
Hazard
Subpotent Drug: Product has an an out of specification in iron assay analysis found during 18 month stability testing.
Sold states
US nationwide
Affected count
5,142 Shelf-packs
Manufactured in
401 Industrial Way West, N/A, Eatontown, NJ, United States
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 NJ 07724 USA, Shelf pack NDC 0143-9570-10, Unit dose NDC 0143-9570-01
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0172-2017Don't want to check this manually?
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