According to the FDA, 21 batches of Potassium Chloride Extended-Release Capsules, USP (750 mg) 10 mEq K, under the Blue Point Laboratories brand, has been recalled by American Health Packaging due to the product’s failed dissolution.
Initiated on June 25, 2024, the consumer-level recall covers batches that were made available via wholesale partners, distributors, and retail outlets across the country. All 21 batches of Potassium Chloride Extended-Release Capsules, which are indicated for treatment of patients with low potassium, come in 100- and 500-count bottles, can be referenced in the FDA communication. Affected products can be found marked with expiration dates as early as 7/31/2024 and as late as 9/30/2025.
Officials took action after fielding concerns that users may suffer hyperkalemia, or high potassium levels, and potentially an irregular heartbeat and then cardiac arrest, because of the product’s failed dissolution. Patients who rely on chronic use of potassium chloride extended-release capsules have a likelihood of developing hyperkalemia, which can show up asymptomatic or manifest as more severe, possibly life-threatening events, including “cardiac arrythmias, severe muscle weakness, and death.” Those who live with comorbidities or conditions that alter their excretory mechanisms for potassium, as in the case of “hypertension, heart failure, or renal dysfunction,” are at even greater risk.
Since the recall announcement, Health Packaging has notified wholesalers and distributing partners of BluePoint Laboratories with direct letters about the product return program. Any distributor or sub-distributor of the products is urged to cease any further distribution, including to retail or pharmacy customers.
While the company has not received any reports of hyperkalemia or other related adverse events connected to the recalled product to date, those in possession of bottles from an affected batch are advised to consult their physician or healthcare provider for personalized feedback about usage. Anyone who experiences health issues believed to be connected to the medical drug should also seek medical attention.
For instructions regarding how to initiate a return of the product, customers should contact Sedgwick, the recall solution vendor, by calling 1-855-695-8564, Monday through Friday, from 8:00 a.m. to 5:00 p.m. Eastern Time.
The FDA asks that anyone who experiences an adverse reaction or quality issue related to the recall report the incident to the agency’s MedWatch program.
If you or a loved one has suffered an adverse health outcome that can be traced to the use of a medical drug with failed dissolution, our experienced attorneys at TruLaw would like to help your family secure the compensation you deserve. We are personally motivated in defending consumer safety standards and holding negligent entities responsible. To learn more about how we can help you navigate the next steps, contact us online or take our free Instant Case Evaluation ℠ .