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

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

When a company announces a recall, market withdrawal, or safety alert, the FDA posts the company's announcement as a public service. FDA does not endorse either the product or the company.

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Summary

Company Announcement Date:
FDA Publish Date:
Product Type:
Drugs
Reason for Announcement:
Recall Reason Description
Failed dissolution
Company Name:
American Health Packaging
Brand Name:
Brand Name(s)
Blue Point Laboratories
Product Description:
Product Description
Potassium Chloride Extended Release 750mg Capsules, 100 count and 500 count

Company Announcement

FOR IMMEDIATE RELEASE – 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:

Sr.
No
NDC Product Name Batch No. Expiry Date
1.                68001-396-00 Potassium Chloride Extended-Release Capsules USP
(750 mg) 10 mEQ K – 100 count
17221738 07/31/2024
2.                68001-396-00 Potassium Chloride Extended-Release Capsules USP
(750 mg) 10 mEQ K – 100 count
17222494 10/31/2024
3.                68001-396-00 Potassium Chloride Extended-Release Capsules USP
(750 mg) 10 mEQ K – 100 count
17230533 01/31/2025
4.                68001-396-00 Potassium Chloride Extended-Release Capsules USP
(750 mg) 10 mEQ K – 100 count
17232208 09/30/2025
5.                68001-396-03 Potassium Chloride Extended-Release Capsules USP
(750 mg) 10 mEQ K – 500 count
17221823 07/31/2024
6.                68001-396-03 Potassium Chloride Extended-Release Capsules USP
(750 mg) 10 mEQ K – 500 count
17221830 07/31/2024
7.                68001-396-03 Potassium Chloride Extended-Release Capsules USP
(750 mg) 10 mEQ K – 500 count
17221831 08/31/2024
8.                68001-396-03 Potassium Chloride Extended-Release Capsules USP
(750 mg) 10 mEQ K – 500 count
17230248 12/31/2024
9.                68001-396-03 Potassium Chloride Extended-Release Capsules USP
(750 mg) 10 mEQ K – 500 count
17230253 12/31/2024
10.             68001-396-03 Potassium Chloride Extended-Release Capsules USP
(750 mg) 10 mEQ K – 500 count
17230271 12/31/2024
11.             68001-396-03 Potassium Chloride Extended-Release Capsules USP
(750 mg) 10 mEQ K – 500 count
17230796 02/28/2025
12.             68001-396-03 Potassium Chloride Extended-Release Capsules USP
(750 mg) 10 mEQ K – 500 count
17230820 02/28/2025
13.             68001-396-03 Potassium Chloride Extended-Release Capsules USP
(750 mg) 10 mEQ K – 500 count
17230825 03/31/2025
14.             68001-396-03 Potassium Chloride Extended-Release Capsules USP
(750 mg) 10 mEQ K – 500 count
17230833 03/31/2025
15.             68001-396-03 Potassium Chloride Extended-Release Capsules USP
(750 mg) 10 mEQ K – 500 count
17230840 03/31/2025
16.             68001-396-03 Potassium Chloride Extended-Release Capsules USP
(750 mg) 10 mEQ K – 500 count
17231537 06/30/2025
17.             68001-396-03 Potassium Chloride Extended-Release Capsules USP
(750 mg) 10 mEQ K – 50 count
17231540 06/30/2025
18.             68001-396-03 Potassium Chloride Extended-Release Capsules USP
(750 mg) 10 mEQ K – 500 count
17231719 06/30/2025
19.             68001-396-03 Potassium Chloride Extended-Release Capsules USP
(750 mg) 10 mEQ K – 500 count
17231737 06/30/2025
20.             68001-396-03 Potassium Chloride Extended-Release Capsules USP
(750 mg) 10 mEQ K – 500 count
17232111 09/30/2025
21.             68001-396-03 Potassium Chloride Extended-Release Capsules USP
(750 mg) 10 mEQ K – 50 count
17232164 09/30/2025

The product can be identified through the labels 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.

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


Company Contact Information

Consumers:
Sedgwick
1- 855-695-8564

Product Photos

 
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