FDA recall D-0172-2017

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

Reason for recall

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

Distribution

US nationwide

Key facts

Status

Terminated

Initiation date

2016-11-17

Report date

2016-12-14

Termination date

2018-04-19

Voluntary/Mandated

Voluntary: Firm initiated

Location

Eatontown, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0172-2017