Potassium chloride FDA Alerts

ICU Medical Issues Nationwide Recall of Potassium Chloride Injection, 20 mEq and Potassium Chloride Injection, 10 mEq Due to Mislabeling

February 13, 2025 LAKE FOREST, Illinois – ICU Medical, Inc. is voluntarily recalling one lot each of POTASSIUM CHLORIDE Inj. bags with overwrap labels 10mEq, packaged in cases of POTASSIUM CHLORIDE Inj. 20 mEq, to the user level. ICU medical has received a customer complaint which states that bags of POTASSIUM CHLORIDE Inj. 20 mEq have incorrect overwrap labels which state POTASSIUM CHLORIDE Inj. 10 mEq.

ICU Medical has identified a potential for some of the product overwraps in one lot being mislabeled as 10 mEq (instead of 20 mEq that is contained in the I.V. Bag) of POTASSIUM CHLORIDE due to a manufacturing issue. The 20 mEq, correctly printed on the labeling affixed to the bag, is not visible or not easily visible without manipulation when the 10 mEq overwrap is in place

Risk Statement: If the Health Care provider mistakenly calculates the patient dose using 10 mEq, the patient will receive an overdose of potassium chloride. Severe hyperkalemia after large intravenous overdoses causes neuromuscular dysfunction including muscle weakness, ascending paralysis, listlessness, vertigo, mental confusion, hypotension, cardiac dysrhythmias, or death from cardiac arrest. Premature infants, patients on chronic parenteral nutrition, patients who have a history of cardiac arrythmias, patients with chronic renal insufficiency, patients who have acute renal failure, patients on potassium-sparing diuretics—all are at risk for adverse and potentially fatal outcomes. ICU Medical has not received reports of adverse events associated with this issue to date.

Potassium Chloride Injection 20 mEq and 10 mEq, is indicated in the treatment of potassium deficiency states, when oral replacement is not feasible and is packaged in 100 mL bags. The mislabeled POTASSIUM CHLORIDE Inj. 20 mEq, 100 mL bags contain incorrect overwrap labels with the following information: NDC 0990-7074-26, 200 mEq/L POTASSIUM CHLORIDE Inj. 10 mEq. The lot 1023172 and Exp. Date 31 January 2026 is found on the primary container (see picture below). These mislabeled bags are packaged in cases labeled: NDC 0990-7075-26, CASE PACK 1x24 – 100ML 20MEQ POTASSIUM CHLORIDE INJECTION LOT NO. 1023172, EXP DATE 2026-01.

DESCRIPTION OF MISLABELLED BAGS BEING RECALLED:

DESCRIPTION OF CASES BEING RECALLED:

ICU Medical is notifying its customers, including distributors, of this recall by letter, and is arranging for the return of all recalled product. All Health Care professionals that have product that is being recalled should stop use/further distribution, as applicable, and return to place of purchase.

Consumers with questions regarding this recall can contact ICU Medical by phone number or e-mail address as indicated in the table below. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product.

For further inquiries, please contact ICU Medical using the information provided below

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

• Complete and submit the report Online: www.fda.gov/medwatch/report.htm
• Regular Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.

American Health Packaging on Behalf of BluePoint Laboratories Issues Recall for Potassium Chloride Extended-Release Capsules, USP (750 mg) 10 mEq K Due to Failed Dissolution

June 25, 2024 – American Health Packaging on behalf of BluePoint Laboratories is voluntarily recalling 21 batches of Potassium Chloride Extended-Release Capsules, USP (750 mg) 10 mEq K, to the consumer level. The product is being recalled because of failed dissolution.

Risk Statement: The failed dissolution of potassium chloride extended-release capsules may cause high potassium levels, also known as hyperkalemia, which can result in irregular heartbeat that can lead to cardiac arrest. For patients who require chronic use of potassium chloride extended-release oral capsules, especially in those patients with underlying comorbidities or conditions that cause altered excretory mechanisms for potassium such as hypertension, heart failure, or renal dysfunction, there is a reasonable probability of developing hyperkalemia that may lead to a range of severity of adverse events from being asymptomatic to more severe potential life threatening adverse events of hyperkalemia such as cardiac arrythmias, severe muscle weakness, and death. To date, the firm has not received any reports of hyperkalemia or serious adverse events from spontaneous sources related to this recall.

Potassium Chloride Extended-Release Capsules are used for the treatment of patients with low potassium (hypokalemia) and are packaged in bottles of 100-count (NDC 68001-396-00) and 500-count (NDC 68001-396-03) capsules.

The Potassium Chloride Extended-Release Capsules being recalled were distributed nationwide to wholesale, distributor, and retail outlets.

The recall includes the lot numbers and expiration dates listed below:

American Health Packaging on behalf of BluePoint Laboratories is notifying its wholesale and distributor customers by written letters and is arranging for return of all recalled batches. Wholesalers, distributors, and retailers that have the recalled products should discontinue distribution of the recalled product lots immediately and follow the instructions provided in the written recall letter. Wholesalers and distributors should conduct a sub-recall to retail or pharmacy customers.

Consumers that have Potassium Chloride Extended-Release Capsules subject to the recall should consult with their physician or health care provider before they stop using the product. Consumers should also contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product. Consumers should call Sedgwick, a recall solution vendor, at 1- 855-695-8564, Monday - Friday, 8:00 am – 5:00 pm EST for return instructions and further information.

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

• Complete and submit the report Online: www.fda.gov/medwatch/report.htm
• Regular Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.

Source: FDA

Glenmark Pharmaceuticals Inc., USA Issues Recall for Potassium Chloride Extended-Release Capsules, USP (750 mg) 10 mEq K Due to Failed Dissolution

June 24, 2024 – Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ is voluntarily recalling 114 batches of Potassium Chloride Extended-Release Capsules, USP (750 mg) 10 mEq K, to the consumer level. The product is being recalled because of failed dissolution.

Risk Statement: The failed dissolution of potassium chloride extended release capsules may cause high potassium levels, also known as hyperkalemia, which can result in irregular heart beat that can lead to cardiac arrest. For patients who require chronic use of potassium chloride extended-release oral capsules, especially in those patients with underlying comorbidities or conditions that cause altered excretory mechanisms for potassium such as hypertension, heart failure, or renal dysfunction, there is a reasonable probability of developing hyperkalemia that may lead to a range of severity of adverse events from being asymptomatic to more severe potential life threatening adverse events of hyperkalemia such as cardiac arrythmias, severe muscle weakness, and death. To date, the firm has not received any reports of hyperkalemia or serious adverse events from spontaneous sources related to this recall.

Potassium Chloride Extended-Release Capsules are used for the treatment of patients with low potassium (hypokalemia) and are packaged in bottles of 100-count (NDC 68462-357-01) and 500-count (NDC 68462-357-05) capsules.

The Potassium Chloride Extended-Release Capsules being recalled were distributed nationwide to wholesale, distributor, and retail outlets.

The recall includes the lot numbers and expiration dates listed below:

Table for the lot numbers and expiration dates.

Glenmark is notifying its wholesale and distributor customers by written letters and is arranging for return of all recalled batches. Wholesalers, distributors, and retailers that have the recalled products should discontinue distribution of the recalled product lots immediately and follow the instructions provided in the written recall letter. Wholesalers and distributors should conduct a sub-recall to retail or pharmacy customers.

Consumers that have Potassium Chloride Extended-Release Capsules subject to the recall should consult with their physician or health care provider before they stop using the product. Consumers should also contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product. Consumers should call Inmar Rx Solutions at 1-877-883-9273, Monday - Friday, 9:00 am – 5:00 pm EST for return instructions and for further information.

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

• Complete and submit the report Online: www.fda.gov/medwatch/report.htm
• Regular Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.

Source: FDA

Highly Concentrated Potassium Chloride Injection, 10 mEq per 100 mL by Baxter: Recall - Mislabeled Overpouch

ISSUE: Baxter International Inc. voluntarily recalled one lot of Highly Concentrated Potassium Chloride Injection, 10 mEq per 100 mL to the user level due to a complaint of mislabeling of the overpouch. Some containers of Product Code 2B0826, Highly Concentrated Potassium Chloride Injection, 10 mEq per 100 mL, Lot Number P319160, Exp. 06/30/2015, NDC 0338-0709-48 were incorrectly labeled on the overpouch as Highly Concentrated Potassium Chloride Injection, 20 mEq per 100 mL.

The inability to detect this overpouch mislabeling at the point of care may result in the administration of a dose lower than intended. In the high-risk patient population – patients prone to severe electrolyte imbalance – this hazardous situation may lead to serious, life-threatening adverse health consequences. There have been no reported adverse events associated with this issue to date.

BACKGROUND: Potassium Chloride is indicated for treatment of potassium deficiency and administered intravenously. Products were distributed to customers in the U.S. between June 23, 2014 and October 2, 2014.

RECOMMENDATION: Baxter has notified customers, who are being directed not to use product from the recalled lot. Recalled product should be returned to Baxter for credit by contacting Baxter Healthcare Center for Service at 1-888-229-0001, Monday through Friday, between the hours of 7:00 a.m. and 6:00 p.m., Central Time. Unaffected lot numbers can continue to be used according to the instructions for use. Unaffected lots of product are available for replacement. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to using this drug product.

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:

• Complete and submit the report Online: www.accessdata.fda.gov/scripts/medwatch/index.cfm
• Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

[11/20/2014 - Press Release - Baxter International Inc]

Potassium Chloride Injection (Baxter): Recall - Shipping Carton Mislabeling

ISSUE: Baxter International Inc. announced a voluntary recall of one lot of Potassium Chloride Injection 10mEq per 100mL, product code 2B0826 (Lot # P318220, NDC # 0338-0709-48) to the hospital/pharmacy/nurse level. The recall is being initiated due to a labeling error on the shipping cartons in a single lot. Shipping cartons labeled for this specific lot number of Potassium Chloride Injection may contain units of Gentamicin Sulfate Injection, 80 mg in 100 mL, product code 2B0862.

As both products are packaged in 100mL containers, have similar code numbers and red labeling on the front panel, there is a potential risk of medication error or delay in therapy for patients that require high concentration potassium chloride.

The affected lot of Potassium Chloride Injection was distributed to customers in the United States between May 26, 2014, and August 8, 2014. There have been no reported adverse events associated with this situation to date.

BACKGROUND: Potassium Chloride is indicated for treatment of potassium deficiency and administered intravenously. Gentamicin Sulfate is an antibacterial drug for intravenous administration.

RECOMMENDATION: It is recommended that healthcare professionals carefully review the product label before administering.

Consumers with questions regarding this recall can call Baxter at 1-800-422-9837, Monday through Friday, between the hours of 8:00 a.m. and 5:00 p.m. Central Time, or e-mail Baxter at onebaxter@baxter.com. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to using this drug product.

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:

• Complete and submit the report Online: www.accessdata.fda.gov/scripts/medwatch/index.cfm
• Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

[09/16/2014 - Firm Press Release - Baxter International, Inc]