Potassium Phosphates Injection - Recall Due to Particulates
April 22, 2011
In February 2011, American Regent voluntarily recalled a single lot of potassium phosphates injection (phosphorus 3 mmol/mL, potassium 4.4 mEq/mL) in 5 mL single dose vials (lot #0048, expiry January 2012). Some vials of the affected lot may contain translucent visible glass particles, caused by delamination of the glass vial surface when placed in contact with a high pH drug solution. These particulates may pose a safety risk if administered to patients.
Avoid administering the affected product and immediately quarantine the recalled vials for return to the manufacturer. Visually assess all parenteral drug products for particulates and color changes before administration. Healthcare providers with questions may contact American Regent at 1-877-788-3232, weekdays from 8:30AM to 7:00PM Eastern Standard Time. American Regent will credit accounts for all returned products from the affected lot. To report adverse effects from the use of any of the recalled lots, contact American Regent at PV@luitpold.com, 1-800-734-9236 (phone), 1-610-650-0170 (fax), or 1-610-650-7781 (fax); or report adverse events to FDA’s MedWatch program.
No other lots have been recalled. However, the company is taking additional steps to protect patient safety, including changing their glass source. The company now recommends filtering all other lots of American Regent potassium phosphates injection prior to administration, using the following protocol:
- Inspect vial for particulates prior to preparation. Discard if any are present.
- Withdraw the desired dose of potassium phosphates injection from the vial, using a 5 micron filter needle. Remove filter needle from the syringe.
- Add the potassium phosphates injection to the desired volume of IV fluid, using a standard needle.
- Inspect the final solution for particulates prior to administration. Discard if any are present.
- Administer the diluted potassium phosphates solution to patient through an administration set with an appropriate in-line filter. Use a 1.2 micron filter for admixtures containing fat emulsion ("lipids"), and a 0.22 micron in-line filter for all other preparations.
Additional information is available at the following links:
- MedWatch Alert:
- Press Release (with list of lot numbers):
- Photographs of vial labels:
- Dear Healthcare Profession letter (about filtering non-recalled lots):
April 22, 2011; University of Utah, Drug Information Service. Copyright 2011, Drug Information Service, University of Utah, Salt Lake City, UT.