SODIUM FERRIC GLUCONATE COMPLEX IN SUCROSE INJECTION — Class III drug recall D-0172-2017
Terminated recall by West-Ward Pharmaceuticals Corp., reported 2016-12-14, distributed nationwide. Subpotent Drug: Product has an an out of specification in iron assay analysis found during 18 month stability
| Recall number | D-0172-2017 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | West-Ward Pharmaceuticals Corp., Eatontown, NJ, United States |
| Recall initiated | 2016-11-17 |
| Classified | 2016-12-08 |
| Reported by FDA | 2016-12-14 |
| Terminated | 2018-04-19 |
| Distributed | Nationwide (US) |
| Quantity | 5,142 shelf |
| Reason classes | potency, specification failure |
| NDC | 00143-9570, 00143-9570-01, 00143-9570-10 |
| Lot numbers | 152032.1 |
| Expiration dates | 2017-02 |
Product
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0172-2017. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.