American Regent Initiates Voluntary Nationwide Recall of Ammonium Molybdate Injection, USP (Molybdenum 250mcg/10 mL) 10 mL Single Dose Vial Due to the Presence of Particulate Matter
American Regent is conducting a nationwide voluntary recall of:
Ammonium Molybdate Injection, USP (Molybdenum 250mcg/10mL) 10mL Single Dose Vial NDC 0517-6610-25, Lot # 9409, Exp. Date June 2011.
PLEASE NOTE: This recall initiated on April 26, 2011 to the User Level is for Lot # 9409 only. No other lots of Ammonium Molybdate Injection, USP are subject to this recall.
This voluntary recall was initiated because some vials of this lot were observed to contain particulates. American Regent is undertaking this recall in consideration of the potential for safety issues if this lot of product is administered to patients. 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.
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.
While American Regent continues to investigate this issue, the company is taking precautionary action and initiated this voluntary recall. American Regent has informed 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/retailers that have product which is being recalled should stop use.
American Regent will credit accounts for all returned product with this lot # 9409. Those with questions about the return or recall process, please call our Customer Service Department at 1-877-788-3232: Monday thru Friday from 8:30AM to 7:00PM ET.
Hospitals, infusion centers, clinics and healthcare providers, or patients with product quality complaints, medical or other questions concerning the use of the product or reasons for this recall should contact the Professional Services Department at: 1-877-788-3232.
Any adverse reactions experienced with the use of this product should be reported to American Regent, Inc. via email at pv@luitpold.com, by fax to (610) 650-0170 or by phone at 1-800-734-9236. TO EXPEDITE HANDLING PLEASE DO NOT REPORT ANYTHING OTHER THAN SPECIFIC ADVERSE EVENTS TO THIS EMAIL ADDRESS OR FAX OR PHONE.
Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program online 1, or regular mail or by fax.
- Online: www.fda.gov/medwatch/report.htm 2
- Regular Mail: use postage-paid, pre-addressed Form FDA 3500 available at: www.fda.gov/MedWatch/getforms.htm 3. Mail to address on the pre-addressed form.
- Fax: 1-800-FDA-0178
Ammonium Molybdate Injection, USP is manufactured by Luitpold Pharmaceuticals, Inc. and is distributed by American Regent, Inc. (Shirley, NY).