Elevated risk U.S. Food and Drug Administration

Blue Point Laboratories Potassium Chloride Extended Release 750mg Capsules recall: Failed dissolution

Recall published 2+ years ago

Failed dissolution

Blue Point Laboratories Prescription & OTC drugs — recalled prescription & otc drugs
Photo published by U.S. Food and Drug Administration with the recall notice.

The hazard: Potency, impurity or stability failure

This is a specification failure: testing showed the product does not match what the label promises.

What the notice says: 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.

Why it matters: The product failed a specification test: it may contain more or less active ingredient than the label states, carry an impurity, or degrade before its expiry date. A sub-potent dose can leave a condition untreated; a super-potent one can cause an overdose.

Symptoms and when to call a doctor

The risk depends entirely on the drug. For a medicine where dose matters closely — a blood thinner, an anti-epileptic, a thyroid or heart medicine, insulin — talk to your prescriber before changing anything. Seek urgent care if you have symptoms that suggest too much drug, or if the condition the medicine controls starts breaking through.

This page is general information, not medical advice. If you feel unwell, a clinician who can see you is the only person able to judge your case.

Recall details

Published
June 25, 2024
Risk level
Elevated risk
Issued by
U.S. Food and Drug Administration
Brand
Blue Point Laboratories
Product type
Prescription & OTC drugs
Distribution
Nationwide

Products covered by this recall

Potassium Chloride Extended Release 750mg Capsules, 100 count and 500 count

What the company announced

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

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.

Reproduced from the company announcement posted on fda.gov. Links and contact forms in the original are not repeated here; the official notice below has them.

Check your product

The notice names 35 codes you can read straight off the package. Type the one printed on yours and the list below narrows to it.

Lot or batch code

Usually ink-stamped near the seam, the cap or the bottom of the pack.

  • 17221738
  • 17222494
  • 17230533
  • 17232208
  • 17221823
  • 17221830
  • 17221831
  • 17230248
  • 17230253
  • 17230271
  • 17230796
  • 17230820
  • 17230825
  • 17230833
  • 17230840
  • 17231537
  • 17231540
  • 17231719
  • 17231737
  • 17232111

Best-by / use-by date

Printed beside the lot code, not on the price sticker.

  • 07/31/2024
  • 10/31/2024
  • 01/31/2025
  • 09/30/2025
  • 08/31/2024
  • 12/31/2024
  • 02/28/2025
  • 03/31/2025
  • 06/30/2025

NDC number

On the carton and again on the bottle or blister label.

  • 68001-396-00
  • 68001-396-03

Package size

Match the net weight or the piece count on the front of the pack.

  • 750 mg
  • 100 count
  • 500 count
  • 50 count

Codes are lifted verbatim from the FDA — Company recall announcements notice. A code that is missing here may still be covered — the official notice is the complete list.

What to do about Potency

Blue Point Laboratories — This is a specification failure: testing showed the product does not match what the label promises.

  1. Check the lot number on your pack against the codes listed above before you do anything else.
  2. Report any change in how the medicine is working to FDA MedWatch, which is where most of these signals originate.
  3. Do not stop a prescription on your own. For most conditions an uncertain dose is safer than no dose while you get advice.
  4. Call your prescriber or pharmacist and ask whether to swap the lot, re-test, or change nothing.

Refunds and replacements

With medicines, a replacement supply matters more than cash, and that is what pharmacies are set up to provide.

  • Ask the dispensing pharmacy for a like-for-like replacement from an unaffected lot. This is the fastest route and usually costs nothing.
  • For a mail-order or online pharmacy, use the recall line listed on this page rather than the general support queue.
  • If the recall voided a fill you had already paid for, your insurer will normally authorise a replacement ahead of schedule. Quote the recall number.
  • If you paid out of pocket, ask for a refund of the co-pay or purchase price and keep the receipt the pharmacy issues.

Company contact: American Health Packaging — Consumers: Sedgwick, 1- 855-695-8564

The official notice

This page summarises a notice published by U.S. Food and Drug Administration. The agency notice is the authoritative version — read it before you act, and treat it as the final word if anything here looks different.

Open the FDA — Company recall announcements record U.S. Food and Drug Administration recalls

Questions people ask about this recall

Why was Blue Point Laboratories prescription & otc drugs recalled?

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.

How do I know if I have the recalled product?

Match the codes printed on your package against the notice: lot code 17221738, 17222494, 17230533; best-by date 07/31/2024 or 10/31/2024. If the code on your package is not on that list, your unit is outside the recall.

What should I do with it right now?

Check the lot number on your pack against the codes listed above before you do anything else.

Can I get my money back?

Ask the dispensing pharmacy for a like-for-like replacement from an unaffected lot. This is the fastest route and usually costs nothing.

Where was the recalled product sold?

It was distributed nationwide.

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