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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