FDA Drug recall D-0172-2017
SODIUM FERRIC GLUCONATE COMPLEX IN SUCROSE INJECTION, 62.5mg elemental iron/5mL, 10 (5mL vials) per shelf pack, Rx only, Mfd: Hikma Farmace…
- FDA Drug
- Class III
- terminated
- Published 2016-12-14
On 2016-12-14 the FDA classified a Class III recall of SODIUM FERRIC GLUCONATE COMPLEX IN SUCROSE INJECTION, 62.5mg elemental iron/5mL, 10 (5mL vials) per shelf pack, Rx only, Mfd: Hikma Farmace… by West Ward Pharmaceuticals, citing subpotent Drug: Product has an an out of specification in iron assay analysis found during 18 month stability testing.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0172-2017 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2016-11-17 |
| Published | 2016-12-14 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | West Ward Pharmaceuticals |
| Distribution | US |
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
Subpotent Drug: Product has an an out of specification in iron assay analysis found during 18 month stability testing.
Identifiers
| ndc | 0143-9570-01 |
|---|---|
| ndc | 0143-9570-10 |
| code_info | Lot #: 152032.1, Exp. Date. 2/2017 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 UTC. Current status: terminated.
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All West Ward Pharmaceuticals recalls
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0172-2017%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.