RecallDepth
Class III Terminated

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

Company
West-Ward Pharmaceuticals Corp.
Recall Initiated
November 17, 2016
Posted
December 14, 2016
Recall Number
D-0172-2017
Voluntary / Mandated
Voluntary: Firm initiated
Quantity
5,142 Shelf-packs
Firm Location
Eatontown, NJ, United States

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

Lot / Code Info

Lot #: 152032.1, Exp. Date. 2/2017

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