American Regent, Inc. Initiates Nationwide Voluntary Recall of Potassium Phosphates Injection, USP, 15 mM/5 mL Phosphorus; 22 mEq/5 mL Potassium, 5 mL Single Dose Vial, Lot # 0048 Due to Translucent Visible Particles
Potassium PhosphatesInjection,USP,15mM/5 mLPhosphorus;22mEq/5mLPotassium
Lot # 0048
PLEASE NOTE: This recall, initiated on February 3, 2011 to the User or Consumer Level, is for lot # 0048 Only. No other lots or sizes of Potassium Phosphates Injection, USP are subject to this voluntary recall.
This voluntary recall was initiated because some vials of this lot exhibit translucent visible particles consistent with glass delamination.
Potential adverse events after intravenous administration include damage to blood vessels in the lung, localized swelling, and granuloma formation. American Regent is undertaking this recall in consideration of the potential for safety issues if this lot of product is administered to patients.
Potassium Phosphates Injection, USP, 3 mM Phosphorus/mL, is indicated as a source of phosphorus, for addition to large volume intravenous fluids to prevent or correct hypophosphatemia in patients with restricted or no oral intake. It is also useful as an additive for preparing specific intravenous fluid formulas when the needs of the patient cannot be met by standard electrolyte or nutrient solutions.
The product was distributed to wholesalers and distributors nationwide.
Hospitals, Home Health Care Agencies, Emergency Rooms, Infusion Centers, Clinics and other healthcare facilities should not use American Regent, Inc., Potassium Phosphates Injection, USP, 15 mM/5 mL Phosphorus; 22 mEq/5 mL Potassium, 5 mL Single Dose Vial, with lot # 0048 for patient care and should immediately quarantine any product for return.
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.
AmericanRegentwill creditaccountsfor all returned productwith this lot#. Thosewith questionsabout thereturnor recallprocess, pleasecall our CustomerServiceDepartment at 1-877-788-3232: Monday thru Friday from8:30AMto7:00PMEST.
Hospitals, Home Health Agencies, Emergency Rooms, Infusion Centers, Clinics and Healthcare Providers,or patients withproduct quality complaints, medicalor otherquestions concerning the useof the product or reasons for this recall should contact the Professional ServicesDepartmentat 1-877-788-3232.
Anyadverse reactions experiencedwiththe use of this product should be reported to AmericanRegent,Inc.viaemailat firstname.lastname@example.org (610)650-7781or (610)650-0170or byphoneat1-800-734-9236. TOEXPEDITE HANDLINGPLEASE DONOT REPORT ANYTHINGOTHERTHANSPECIFIC 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, or regular mail or by fax.
- Online: www.fda.gov/medwatch/report.htm
- 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.
- Fax: 1-800-FDA-0178
"All of us at American Regent and Luitpold are taking the necessary steps to protect patients from any potential safety risks with our Potassium Phosphates Injection. The safety and well being of patients receiving our products is our primary concern," said Mary Jane Helenek, President and CEO of American Regent.
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 Potassium Phosphates Injection, USP, Product Package Insert, "Parenteraldrugproducts shouldbeinspectedvisually for particulate matterand discoloration priortoadministration,wheneversolution andcontainer permit."
Potassium Phosphates Injection, USP is manufactured by Luitpold Pharmaceuticals, Inc. and is distributed by American Regent, Inc. (Shirley, NY).
Source: Luitpold Pharmaceuticals, Inc.
This voluntary recall is being conducted with the knowledge of the U.S. Food and Drug Administration.
SOURCE Luitpold Pharmaceuticals, Inc.