CLASS III Drug recall · Reported 14 Dec 2016 · FDA Enforcement Report
Sodium Ferric Gluconate Complex IN Sucrose Injection recalled
West-Ward Pharmaceuticals is recalling Sodium Ferric Gluconate Complex IN Sucrose Injection, 62.5mg elemental iron/, 10 vials), distributed nationwide in the US. The recall was initiated on 17 Nov 2016 and the FDA has classified it as Class III.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0172-2017
- FDA event ID
- 75784
- Recalling firm
- West-Ward Pharmaceuticals, Eatontown, NJ
- Manufacturer
- Hikma Pharmaceuticals USA Inc.
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 17 Nov 2016
- FDA classified
- 8 Dec 2016
- Reported
- 14 Dec 2016
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Drug class
- Injectable & IV Drugs
Timeline
| 17 Nov 2016 | Recall initiated by company | |
| 8 Dec 2016 | Classified by FDA | +21 days |
| 14 Dec 2016 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Subpotent Drug: Product has an an out of specification in iron assay analysis found during 18 month stability testing.
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
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
Where it was distributed
US nationwide
Questions about this recall
Why was it recalled?
Subpotent Drug: Product has an an out of specification in iron assay analysis found during 18 month stability testing.
Which lots are affected?
Lot #: 152032.1, Exp. Date. 2/2017
Where was it sold?
US nationwide
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class III mean?
Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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