D-0172-2017 Class III Terminated
FDA drug recall D-0172-2017 was initiated by West-Ward Pharmaceuticals Corp. on Nov 17, 2016 and is designated Class III. Reason for recall: Subpotent Drug: Product has an an out of specification in iron assay analysis found during 18 month stability testing. The recall status is terminated (terminated Apr 19, 2018). Affected quantity: 5,142 Shelf-packs.
Recall details
- Product Type
- Drugs
- Report Date
- Dec 14, 2016
- Initiation Date
- Nov 17, 2016
- Termination Date
- Apr 19, 2018
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 5,142 Shelf-packs
Product description
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.
Distribution pattern
US nationwide
Code information
Lot #: 152032.1, Exp. Date. 2/2017
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0172-2017
- openFDA file date
- Nov 10, 2026
- Loaded by RegDataLab
- Nov 11, 2026