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Potassium phosphate FDA Alerts

The FDA Alerts below may be specifically about potassium phosphate or relate to a group or class of drugs which include potassium phosphate.

MedWatch Safety Alerts are distributed by the FDA and published by Drugs.com. Following is a list of possible medication recalls, market withdrawals, alerts and warnings.

Recent FDA Alerts for potassium phosphate

Infants at Risk for Aluminum Toxicity with Unapproved Potassium Phosphates Drug Product

Feb 9, 2023 | Audience: Consumers
February 9, 2023 -- FDA is warning health care professionals and pharmacies to avoid using Hospira's unapproved potassium phosphates drug product in pediatric patients because the aluminum exposure from this product is unsafe for this population.

This product alone may produce daily aluminum exposures of up to twice the FDA-recommended limit for parenteral nutrition, with additional aluminum exposure expected from the other components of parenteral nutrition.

FDA recommends health care providers use an FDA-approved potassium phosphates injection product with the aluminum content level considered acceptable for each patient based on age, weight, and recommended dose of phosphorus.

  • FDA considers Fresenius Kabi’s product appropriate for patients of all ages.
  • FDA considers CMP Development’s product is appropriate for pediatric patients 12 years of age and older who weigh at least 40 kg and adults weighing at least 45 kg.

These FDA-approved products provide detailed dosing instructions for preparation and administration to minimize the risk of aluminum toxicity.

The potassium phosphates injections are phosphorus replacement products intended for use as a source of phosphorus in IV fluids to correct hypophosphatemia and for parenteral nutrition in adults and pediatric patients. Patients on prolonged courses of parenteral nutrition support are at greatest risk of exposure to toxic levels of aluminum. Exposure to toxic levels of aluminum can lead to softening of the bones (osteomalacia), reduced bone mineralization, neurological dysfunction, microcytic hypochromic anemia, and reduction or stoppage of bile flow (cholestasis).

In December 2022, FDA issued a draft guidance for industry that clarifies the key factors in determining the appropriate aluminum limit in a small volume parenteral drug or pharmacy bulk package for products approved for use in parenteral nutrition. FDA’s guidance includes a recommendation that the total allowable aluminum exposure from parenteral nutrition should not exceed 5 mcg/kg/day.

FDA has requested that the unapproved product sponsor manufacturer revise its labeling to reflect that use of the product in pediatric patients is not recommended because of the risk of aluminum toxicity. Learn more about unapproved marketed drug products on FDA’s Unapproved Drugs page.

FDA encourages health care professionals and patients to report adverse events or quality problems with any medicine to FDA’s MedWatch Adverse Event Reporting program:

  • Complete and submit the report online at Medwatch; or
  • Download and complete the form, then submit it via fax at 1-800-FDA-0178.

Source: FDA

Potassium Phosphate and Succinylcholine Chloride by PharMEDium Services: Recall - Lack of Sterility Assurance

Jun 27, 2017 | Audience: Pharmacy

[Posted 06/27/2017]

ISSUE: PharMEDium Services is conducting a limited, voluntary recall due to Hospira Inc.’s (“Hospira”) June 15, 2017 recall announcement that microbial growth was detected during a routine simulation of the manufacturing process and therefore there was a lack of sterility assurance. The products being recalled by PharMEDium Services were compounded using certain Hospira products. The recalled products are specific lots of Potassium Phosphate and Succinylcholine Chloride. This is a secondary recall based on a Hospira's recent recall: https://www.fda.gov/Safety/Recalls/ucm563383.htm.

Per Hospira, in the event that impacted product is administered to a patient, there is a reasonable probability that the patient may experience adverse events ranging from fever, chills and malaise, to severe adverse events including systemic invasive mycoses or systemic bacterial sepsis. The possibility of a breach in sterility assurance in distributed product, while remote, cannot be eliminated.

Refer to the recall notice for a list of the recalled lots and product photos.

BACKGROUND: These products were not distributed directly to patients or consumers, but rather to healthcare facilities (e.g. hospitals) in the United States.

RECOMMENDATION: PharMEDium Services is notifying customers of the voluntary recall by phone. Customers that have any of the affected medications that are being recalled should immediately quarantine the product, discontinue use and destroy per their hospital protocol. 

Patients and healthcare providers with questions regarding this recall can contact PharMEDium Services Clinical Pharmacist at (847) 457-2220, Monday through Friday, between 8am and 5pm Central Standard Time.

Patients should contact their physician or healthcare provider if they have experienced any problems that may be related to the use of these products.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

 

[06/26/2017 - Recall Notice - PharMEDium Services]

Potassium Phosphate and Succinylcholine by Advanced Pharma: Recall - Potential Lack of Sterility Assurance

Jun 22, 2017 | Audience: Pharmacy

ISSUE: Advanced Pharma, Inc. d/b/a Avella of Houston is conducting a limited, voluntary recall due to Hospira Inc.’s June 15, 2017 recall announcement that microbial growth was detected during a routine simulation of the manufacturing process and therefore there was a lack of sterility assurance. The products being recalled by Advanced Pharma were repackaged and/or compounded at its Houston, Texas facility using certain Hospira products. The recalled products are specific lots of Potassium Phosphate and Succinylcholine Chloride. This is a secondary recall based on a Hospira's recent recall.

Per Hospira, in the event that impacted product is administered to a patient, there is a reasonable probability that the patient may experience adverse events ranging from fever, chills and malaise, to severe adverse events including systemic invasive mycoses or systemic bacterial sepsis. The possibility of a breach in sterility assurance in distributed product, while remote, cannot be eliminated.

BACKGROUND: These products were not distributed directly to patients or consumers, but rather to healthcare facilities (e.g. hospitals).

RECOMMENDATION: Avella and Advanced Pharma are notifying customers of the voluntary recall by phone, email and overnight mail. Customers in Arizona, California, Colorado, Delaware, Georgia, Louisiana, Nebraska, New Jersey, North Carolina, Ohio, Pennsylvania, South Carolina, Tennessee, Texas, Utah and Washington that have any of the affected medications that are being recalled should immediately discontinue use and return the unused portion to Avella Specialty Pharmacy. Customers with any of the affected medications can also reference Advanced Pharma’s website for more information on the specific lot numbers affected, product images, forms and contact information: www.avella.com/AP-Hospira-recall.  For a full list of Advanced Pharma products, please visit www.avella.com/sourceb-products.

Patients and healthcare providers with questions regarding this recall can contact Avella Specialty Pharmacy recall line at (877) 292-4323, Monday through Friday, between 6am and 6pm Pacific Standard Time or via e-mail at ProductRecall@avella.com. Patients should contact their physician or healthcare provider if they have experienced any problems that may be related to the use of these products.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

[06/22/2017 - Press Release - Advanced Pharma]
[06/17/2017 - FDA updates on Pfizer drug shortages - FDA]

Sodium Bicarbonate Injection 8.4 Percent USP, Neut (Sodium Bicarbonate 4 Percent Additive Solution), Quelicin (Succinylcholine Chloride Injection USP), and Potassium Phosphates Injection by Hospira: Recall - Potential For Lack Of Sterility Assurance

Jun 15, 2017 | Audience: Pharmacy, Critical Care Medicine, Nursing

ISSUE: Hospira, Inc., a Pfizer company, is voluntarily recalling 42 lots of 8.4% Sodium Bicarbonate Injection, USP, 50 mL vials, 5 lots of NeutTM (Sodium Bicarbonate 4% additive solution) 5 mL vials, 5 lots of QUELICINTM (Succinylcholine Chloride Injection, USP) 200 mg/10 mL vials and 7 lots of Potassium Phosphates Injection, USP, 45 mM vials to the hospital/retail level due to microbial growth detected during a routine simulation of the manufacturing process, which represents the potential introduction of microorganisms into the products. Please view the recall notice for a list of the affected lot numbers.

In the event that impacted product is administered to a patient, there is a reasonable probability that the patient may experience adverse events ranging from fever, chills and malaise, to severe adverse events including systemic invasive mycoses or systemic bacterial sepsis. The possibility of a breach in sterility assurance in distributed product, while remote, cannot be eliminated. No batches of distributed product have been identified as actually containing microorganisms. To date, Hospira has not received reports of any adverse events associated with this issue.

These lots were distributed nationwide in the U.S. (including Puerto Rico), Dutch Antilles, Barbados, Canada, Philippines, Kuwait, and Singapore to wholesalers and hospitals from January to June 2017. Hospira has initiated an investigation to determine the root cause and corrective and preventive actions.
 
Pfizer is working diligently to restore supply of these products and is in communication with the FDA to address any supply issues.

BACKGROUND: Sodium Bicarbonate Injection, USP is indicated in the treatment of metabolic acidosis; in the treatment of certain drug intoxications, in poisoning by salicylates or methyl alcohol and in certain hemolytic reactions. Sodium bicarbonate is indicated in severe diarrhea, which is often accompanied by significant loss of bicarbonate. NeutTM (4% sodium bicarbonate additive solution) is indicated for use as an additive to raise the pH of acid solutions administered intravenously to reduce the incidence of chemical phlebitis and patient discomfort due to vein irritation at or near the site of infusion.

QuelicinTM (Succinylcholine Chloride Injection, USP) is indicated as an adjunct to general anesthesia, to facilitate tracheal intubation, and to provide skeletal muscle relaxation during surgery or mechanical ventilation.

Potassium Phosphates Injection, USP 3 mM P/mL (millimoles/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.

RECOMMENDATION: Anyone with an existing inventory of the recalled lots should stop use and distribution and quarantine immediately. Inform Healthcare Professionals in your organization of this recall. If you have further distributed the recalled product, please notify any accounts or additional locations which may have received the recalled product from you. Further, please instruct entities that may have received the recalled product from you that if they redistributed the product, they should notify their accounts, locations or facilities of the recall to the hospital/retail level. Hospira will be notifying its direct customers via a recall letter and is arranging for impacted product to be returned to Stericycle in the United States. For additional assistance, call Stericycle at 1-800-805-3093 between the hours of 8 a.m. to 5 p.m. ET, Monday through Friday.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:


[06/15/2017 - Recall Notice - Hospira, a Pfizer company]

[06/15/2017 - CDER Statement- Updates on Pfizer drug shortages - FDA]

American Regent Injectable Products: Recall - Visible Particulates in Products

Jun 7, 2011 | Audience: Pharmacy
  • Methyldopate HCL Injection, USP 5ml Single Dose Vial
  • Caffeine & Sodium Benzoate Injection, USP, 250 mg/mL, 2 mL Single Dose Vial
  • Ammonium Molybdate Injection, USP (Molybdenum 250mcg/10 mL) 10 mL Single Dose Vial
  • Dexamethasone Sodium Phosphate Injection, 4 mg/mL, 1 mL Single Dose Vials; 5 mL and 30 mL Multiple Dose Vials
  • Bacteriostatic Sodium Chloride Injection, USP, 0.9%, 30 mL Multiple Dose Vials
  • Concentrated Sodium Chloride Injection, USP 23.4%, 30 mL Single Dose Vials and 100mL Pharmacy Bulk Packages
  • Sodium Thiosulfate Injection USP 10%
  • Potassium Phosphates Injection, USP

 

[UPDATED 06/07/2011] Methyldopate HCL Injection, USP 5ml Single Dose Vial recalled.

[UPDATED 05/06/2011] Caffeine & Sodium Benzoate Injection, USP, 250 mg/mL, 2 mL Single Dose Vial recalled.

[UPDATED 04/27/2011] Ammonium Molybdate Injection, USP (Molybdenum 250mcg/10 mL) 10 mL Single Dose Vial recalled.

[UPDATED 03/18/2011]  Dexamethasone Sodium Phosphate Injection products recalled.

[UPDATED 03/17/2011] Concentrated Sodium Chloride Injection products recalled.

[Posted 02/05/2011]

ISSUE: Recall initiated because some vials 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.

BACKGROUND: Glass delamination can occur with high pH solutions when the surface glass from the vial separates into thin layers, resulting in glass particles with a flaky appearance.

RECOMMENDATION: Hospitals, Home Health Care Agencies, Emergency Rooms, Infusion Centers, Clinics and other healthcare facilities should not use the recalled American Regent products. Recalled products should be immediately quarantined for return. Refer to Press Releases for specific lot numbers recalled.

 

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

 

[06/06/2011 - Press Release, Methyldopate HCL Injection - American Regent]
[05/05/2011 - Press Release, Caffeine & Sodium Benzoate Injection - American Regent]
[04/26/2011 - Press Release, Ammonium Molybdate Injection - American Regent]
[03/16/2011 - Press Release, Dexamethasone Sodium Phosphate - American Regent]
[03/15/2011 - Press Release, Bacteriostatic Sodium Chloride - American Regent] 
[03/15/2011 - Press Release, Concentrated Sodium Chloride - American Regent] 
[02/04/2011 - Press Release, Sodium Thiosulfate - American Regent]
[02/03/2011 - Press Release, Potassium Phosphates - American Regent]   

Previous, related product alerts:

[12/24/2010 - Dexamethasone Sodium Phosphate Injection]
[12/29/2010 - Sodium Bicarbonate Injection]

American Regent Injectable Products: Recall - Visible Particulates in Products

Feb 5, 2011 | Audience: Pharmacy
  • Sodium Thiosulfate Injection USP 10%
  • Potassium Phosphates Injection, USP

 

[Posted 02/05/2011]

ISSUE: Recall initiated because some vials 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.

BACKGROUND: Glass delamination can occur with high pH solutions when the surface glass from the vial separates into thin layers, resulting in glass particles with a flaky appearance.

RECOMMENDATION: Hospitals, Home Health Care Agencies, Emergency Rooms, Infusion Centers, Clinics and other healthcare facilities should not use the recalled American Regent products. Recalled products should be immediately quarantined for return. Refer to Press Releases for specific lot numbers recalled.

 

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

 

[02/04/2011 - Press Release, Sodium Thiosulfate - American Regent]
[02/03/2011 - Press Release, Potassium Phosphates - American Regent]   

Previous, related product alerts:

[12/24/2010 - Dexamethasone Sodium Phosphate Injection]
[12/29/2010 - Sodium Bicarbonate Injection]

    

More potassium phosphate resources