FDA Recall of Potassium Capsules

The FDA has announced a recall of extended-release Potassium Chloride capsules due to a failure to dissolve as intended. When functioning properly, the drug is slowly released into the patient’s system, allowing for proper processing. However, failure of the dissolution process may lead to sudden release of the entirety of the capsule, causing severe and dangerous health outcomes.

As of the writing of this notice, the FDA has not announced any adverse events related to the contamination.

SUMMARY

Date of Recall:

Announced: June 24, 2024

Public Notification: June 25, 2024

Name(s) of Drug:

Potassium Chloride Extended-Release Capsules USP (750 mg) 10 mEq K

Company Name:

Glenmark Pharmaceuticals, Inc.

Drug Indication:

Potassium Supplementation

Product Description

Potassium Chloride Extended-Release Capsules are available by prescription only. Pharmacies nationwide distributed the capsules to the facility and consumer levels. Each was packaged in either 100-count or 500-count bottles and labeled clearly with an orange and white label. The NDC number, expiration date, batch number, and product name are clearly printed on the package.

Reason for Recall

Glenmark Pharmaceuticals, Inc., is voluntarily initiating the recall. They have not publicly stated how the failed dissolution was discovered, but the FDA report states that no serious adverse events have been reported as a result of the failure.

Impacts

Consumers who continue to use the faulty drug may experience serious health outcomes related to a sudden increase in their potassium levels. High potassium levels may lead to effects such as:

• Irregular heartbeat
• Cardiac arrest (heart attack)
• Severe muscle weakness
• Death

Recall Lot Information

All medical facilities and distributors who stock Potassium Chloride Capsules and consumers who take the capsules must carefully examine their inventory to determine if their product is included in the recall. Compare each bottle’s NDC and lot numbers, strength, and expiration date to the chart below. If any are found to match, read further for instructions on participating in the recall.

FDA.gov

Have you found that your medication is part of the recall? Here’s what you should do:

Consumer Recall Instructions

If you find that your lot of medication is part of this recall, do the following:

1. Do not take the recalled medication.
2. Ask your doctor to replace the recalled drug with a new bottle. If the lot number, NDC number, and expiration date do not match the chart, the medication is not included in this recall.
3. If you are currently experiencing or have experienced an adverse reaction to this medication (listed above), notify your physician immediately and notify the FDA by calling 1-800-332-1088 or completing an online reporting form.

Healthcare System Recall Instructions

1. Examine all inventory and remove stock affected by the recall immediately.
2. If you have questions, contact Inmar RX Solutions at 1-877-883-9273. They are available from 9 a.m. to 5 p.m. EST, Monday through Friday.
3. Contact MedWaste Management for information and assistance with disposing of the recalled medication.

Wholesaler/Retailer Recall Instructions

1. Examine all inventory and remove stock affected by the recall immediately.
2. If you have questions, contact Inmar RX Solutions at 1-877-883-9273. They are available from 9 a.m. to 5 p.m. EST, Monday through Friday. Notify them of any recalled batches that have already been shipped to medical facilities or been distributed to consumers.
3. Notify affected medical facilities and consumers of recalled batches that they have already or will receive.
4. Contact MedWaste Management for information and assistance with disposing of the recalled medication.

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Tammy McKinney, RN, founder of HelpfulHospiceNurse, is a healthcare writer and seasoned registered nurse. With experience in acute care, long-term care, rehabilitation, drug & alcohol, and hospice & palliative care, she combines her medical understanding with her love for writing to educate and inform the public on various health-related topics. You can view a snippet of her portfolio here or contact her directly on LinkedIn!