SODIUM FERRIC GLUCONATE COMPLEX IN SUCROSE INJECTION, 62.5mg elemental iron/5mL, 10 (5mL vials) per shelf pack, Rx only, Mfd: Hikma Farm...
FDA Recall Notice
Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-D-0172-2017.
Subpotent Drug: Product has an an out of specification in iron assay analysis found during 18 month stability testing.
Corrective Action (per FDA)
Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-D-0172-2017.
Recall terminated by FDA.
🩺 Talk to your doctor or pharmacist
Product Recall Tracker does not provide medical advice. Any specific instructions about this medication or device come directly from the FDA notice above. Before making any change to your treatment:
- Do not stop, change, or discard your prescription on your own.
- Call your doctor or pharmacist and ask whether this FDA notice applies to your prescription (have the brand name, dosage, and lot number ready if you can find them).
- Follow your clinician's guidance on whether to continue, switch, or return the product.
- If you have experienced a reaction, seek medical care and report it to the FDA via MedWatch.
- For the official FDA notice, visit the FDA recalls page.
Consumer Contact (per FDA)
Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-D-0172-2017.
West-Ward Pharmaceuticals Corp.
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The FDA regulates drugs, medical devices, food, cosmetics, and tobacco. Adverse event reports and recall notices are the main public safety signal.
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If you had an adverse reaction, side effect, or device malfunction from this medication or device, report it to the FDA through MedWatch. Talk to your doctor or pharmacist first — do not stop a prescription on your own. Reports help the FDA detect rare or emerging safety signals and can lead to label changes or recalls.
West-ward Pharmaceuticals Corp. Recall FAQ
West-ward Pharmaceuticals Corp. is the subject of an injectable drugs safety report: SODIUM FERRIC GLUCONATE COMPLEX IN SUCROSE INJECTION, 62.5mg elemental iron/5mL, 10 (5mL vials) per shelf pack, Rx only, Mfd: Hikma Farm.... The notice was published on November 17, 2016 by the U.S. Food and Drug Administration (FDA). Approximately 5,142 units are potentially affected.