American Regent Recalls Ammonium Molybdate Injection

American Regent of Shirley, New York, is recalling its <"http://www.yourlawyer.com/practice_areas/defective_drugs">Ammonium Molybdate Injection, USP (Molybdenum 250mcg/10mL) 10mL Single Dose Vial NDC 0517-6610-25, Lot # 9409, Exp. Date June 2011, the U.S. Food and Drug Administration (FDA) just announced.

According to the FDA, the recall was initiated on April 26, 2011 at the User Level and only involves Lot # 9409. No other lots of Ammonium Molybdate Injection, USP are subject to this recall.

Some vials of this lot were observed to contain particulates. Potential adverse events after intravenous administration of solutions containing particulates may include disruption of blood flow within small blood vessels in the lungs, localized inflammation (swelling and accumulation of inflammatory cells), and granuloma formation.

Ammonium Molybdate Injection, USP is indicated for use as a supplement to Total Parenteral Nutrition (TPN) solutions. Administration of Molybdenum in TPN solutions helps to prevent depletion of endogenous stores and subsequent deficiency symptoms.

The product was distributed to wholesalers and distributors nationwide. Ammonium Molybdate Injection, USP is manufactured by Luitpold Pharmaceuticals, Inc. and is distributed by American Regent, Inc. (Shirley, NY).

Hospitals, Infusion Centers, Clinics, and other healthcare facilities should not use American Regent Inc., Ammonium Molybdate Injection, USP, Lot # 9409, for patient care and should immediately quarantine any product for return.

American Regent continues to investigate this issue and has advised the FDA of its actions and is maintaining ongoing discussions with the Agency.

As is standard practice, and as stated in the Ammonium Molybdate Injection, USP, Product Package Insert, “Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.”

American Regent is notifying its distributors and consumers by email, facsimile, and/or overnight courier and is arranging for return of all recalled product. Consumers, distributors, and retailers in possession of this recalled medication should stop its use.

American Regent said it will credit accounts for all returned product with lot # 9409. The American Regent Customer Service Department can be reached, toll-free, at 1.877.788.3232, Monday through Friday, from 8:30 a.m. to 7:00 p.m., Eastern Time. The Professional Services department can be reached at 1.877.788.3232.

Adverse reactions should be reported to American Regent, Inc. via email at pv@luitpold.com, by fax to 1.610.650.0170, or by telephone at 1.800.734.9236. Adverse reactions or quality problems experienced with the use of this product may also be reported to the FDA’s MedWatch Adverse Event Reporting program online, or regular mail or by fax: Online: www.fda.gov/medwatch/report.htm; by Regular Mail: use postage-paid, pre-addressed Form FDA 3500 available at: www.fda.gov/MedWatch/getforms.htm. Mail to address on the pre-addressed form; and by Fax to: 1.800.FDA.0178.

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