West-Ward Pharmaceuticals Corp. recalls SODIUM FERRIC GLUCONATE COMPLEX IN SUCROSE INJECTION, 62.5mg elemental iron/5mL, 10 (5mL vials) per shelf pack, Rx only…
- Recall date
- November 17, 2016
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- D-0172-2017
- FDA classification
- Class III
- Brand / firm
- West-Ward Pharmaceuticals Corp.
- Sold / distributed
- US nationwide
Why it was recalled
Subpotent Drug: Product has an an out of specification in iron assay analysis found during 18 month stability testing.
Class III means the product violates regulations but is not likely to cause harm.
What 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
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