Reported Dec 14, 2016 · Terminated
SODIUM FERRIC GLUCONATE COMPLEX IN SUCROSE INJECTION, 62.5mg elemental iron/5mL, 10 (5mL vials) per shelf pack, Rx…
West-Ward Pharmaceuticals Corp.
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: West-Ward Pharmaceuticals Corp. · 401 Industrial Way West · Eatontown, NJ · 07724-2209
Is this the product you have?
- SODIUM FERRIC GLUCONATE COMPLEX IN SUCROSE INJECTION, 62.5mg elemental iron/5mL, 10 (5mL vials) per shelf pack, Rx only
- MfdHikma Farmaceutica (Portugal,)
- SA Distributed by
Westward Eatowntown NJ 07724 USAShelf pack NDC 0143-9570-10Unit dose NDC 0143-9570-01
- Lot codes and dates
Lot #: 152032.1Exp. Date. 2/2017
- Amount recalled
- 5,142 Shelf-packs
Where it was sold
- Nationwide
Why it was recalled
Subpotent Drug: Product has an an out of specification in iron assay analysis found during 18 month stability testing.
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
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