Sodium Ferric Gluconate Complex In Sucrose Injection
FDA Recall NDC 0143-9570
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 1 recorded enforcement report(s) associated with Sodium Ferric Gluconate Complex In Sucrose (NDC 0143-9570). A significant event, classified as Class III, was initiated on Nov 17, 2016 by Hikma Pharmaceuticals Usa Inc.. The reported reason for this action was: "Subpotent Drug: Product has an an out of specification in iron assay analysis found during 18 month stability testing."
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
Reported Recall Events
Class III Terminated
Subpotent Drug: Product has an an out of specification in iron assay analysis found during 18 month stability testing.
Nov 17, 2016
Dec 14, 2016
5,142 Shelf-packs
Recall Profile & Regulatory Data
Event ID
75784
Classification
Class III
Enforcement Status
Terminated
Recalling Firm
West-Ward Pharmaceuticals Corp.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
US nationwide
Termination Date
Apr 19, 2018
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
Batch or Lot Expiration Information
Lot# : 152032.1, Exp. Date. 2/2017
Affected Packages Involved in this Recall
0143-9570-01Product
0143-9570-10Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
