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
Reported: December 14, 2016 Initiated: November 17, 2016 #D-0172-2017
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.
Details
- Recalling Firm
- West-Ward Pharmaceuticals Corp.
- Units Affected
- 5,142 Shelf-packs
- Distribution
- US nationwide
- Location
- Eatontown, NJ
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by West-Ward Pharmaceuticals Corp.. Units affected: 5,142 Shelf-packs.
Why was this product recalled? ▼
Subpotent Drug: Product has an an out of specification in iron assay analysis found during 18 month stability testing.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on December 14, 2016. Severity: Low. Recall number: D-0172-2017.
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