FDANovember 11, 2024drug
Venofer (iron sucrose) Injection, USP 100 mg Elemental Iron per 5 mL (20 mg/mL), 5 mL Single-Dose Vials, Rx Only, For Intravenous Use Only, American Regent, Inc. Shirley, NY 11967, NDC: 0517-2340-01 (vial), NDC: 0517-2340-10 (10 x 5 mL/vial cartons), NDC: 0517-2340-25 (25 x 5 mL/vial cartons).
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
Presence of Particulate Matter: Potential for glass delamination from the vials.
What to do
FDA enforcement status: Ongoing
Brands named
american regentamerican
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
- CPSCLithium Coin Batteries Recalled Due to Battery Ingestion; Violates Federal Statute for Child-Resistant Packaging of Coin Batteries; Imported by Proudly American Store, of Canada2026-05-28
- CPSCAmerican Honda Motor Recalls Off-Road Motorcycles Due to Risk of Serious Injury or Death Due to Crash Hazard2026-04-30
- FDALevocarnitine Injection, USP, 1 g/5 mL (200 mg/mL), 5 mL Single-Dose Vial, For intravenous use, Rx Only, American Regent, Inc., Shirley, NY 11967. NDC: 0517-1045-012026-04-16
- FDAAIDBAGs are first aid kits of convenience composed of individually labeled devices designed as specialty first aid kits designed for the appropriate level provider to evaluate and treat patients at the point-of-injury / point-of-illness. The original manufacturer labeling, including single use in...2026-03-27
- FDAConvenience kits containing Medline Namic Angiographic Control Syringes with Rotating Adaptor CORONARY ANGIO PACK Model numbers ANCA80AP ANCA80AQ2026-03-19
- FDAPepsin Full Strength Powder, 50 kg, Item #5000545, American Laboratories 5036 South 33rd Street, Omaha, Nebraska 68107. Packed in double poly-lined cardboard drums or boxes.2026-02-26
- FDAPepsin 1:10,000 Powder, 10 kg, Item #FTI-G0193-00, American Laboratories 5036 South 33rd Street, Omaha, Nebraska 68107. Packed in double poly-lined cardboard drums or boxes.2026-02-26
- FDAPepsin 1:3000 Powder, 50 kg, Item #FTI-G0193-00, American Laboratories 5036 South 33rd Street, Omaha, Nebraska 68107. Packed in double poly-lined cardboard drums or boxes.2026-02-26
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