FDA MedWatch – Potassium Chloride Extended-Release Capsules USP, (750 mg) 10 mEq by Blue Point Laboratories

TOPIC: Potassium Chloride Extended-Release Capsules USP, (750 mg) 10 mEq by Blue Point Laboratories: Recall – Due to Failed Dissolution

AUDIENCE: Patient, Health Professional, Pharmacy, Cardiology

ISSUE: American Health Packaging on behalf of BluePoint Laboratories is recalling 21 batches of Potassium Chloride Extended-Release Capsules USP, (750 mg) 10 mEq 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.

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

For more information about this recall, click on the red button “Read Recall“ below.

BACKGROUND: Potassium Chloride Extended-Release Capsules are used for the treatment of patients with low potassium (hypokalemia).

RECOMMENDATIONS: 

• Patients 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.

• Patients 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 for return instructions and further information.

• 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.

Health 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.
• Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on form, or submit by fax to 1-800-FDA-0178.

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