SODIUM FERRIC GLUCONATE COMPLEX IN SUCROSE INJECTION, 62.5mg elemental iron/5mL, 10 (5mL vials) p...
FDA Recall #D-0172-2017 — Class III — November 17, 2016
Product Description
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.
Recalling Firm
West-Ward Pharmaceuticals Corp. — Eatontown, NJ
Classification
Class III — Not likely to cause adverse health consequences.
Product Type
Drugs
Product Quantity
5,142 Shelf-packs
Distribution
US nationwide
Code Information
Lot #: 152032.1, Exp. Date. 2/2017
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated