American Regent Recalls One Lot of Potassium Phosphates Injection Due to Particulate Contamination
The following recall is being posted as some veterinarians may use this product in treating their patients.
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American Regent is conducting a nationwide voluntary recall to the consumer and user level of the following product:
Potassium Phosphates Injection, USP, 15 mM/5 mL Phosphorus; 22 mEq/5 mL Potassium 5 mL Single Dose Vial
- NDC # 0517-2305-25
- Lot #0048
- Exp Date: January, 2012
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.
Published: February 7, 2011; Updated: February 7, 2011
Filed Under: Recalls Warnings
Author: Oregon Veterinary Medical Association