Federal officials have made the decision to recall 135 batches of capsules that have the potential to cause cardiac arrest in consumers due to flaws in the medication. The recall consists of 114 batches of potassium chloride extended-release capsules by Glenmark Pharmaceuticals and 21 batches of the same capsules by American Health Packaging on behalf of BluePoint Laboratories.
The recall was issued voluntarily because of the capsules’ failed dissolution, which could result in high potassium levels, also known as hyperkalemia, as stated by the US Food and Drug Administration. Hyperkalemia can lead to irregular heartbeats that may eventually cause cardiac arrest, the FDA has warned. The recall took place last week following an FDA notice.
Glenmark initiated its recall last Monday, with BluePoint following suit the next day. Both companies manufacture the same capsules, as reported by the Miami Herald. According to the FDA, there have been no reports of hyperkalemia or any serious adverse events related to the recall from spontaneous sources.
The capsules are meant for individuals with low potassium levels, or hypokalemia, and are available in bottles containing 100 and 500 capsules. The FDA has listed the recalled batch numbers for both Glenmark and BluePoint on its website. Consumers who have the recalled Potassium Chloride Extended-Release Capsules are advised to consult their physician or healthcare provider before stopping the use of the product.
FDA officials recommend that consumers contact their healthcare provider if they have experienced any problems that may be connected to taking or using this drug product. It is crucial for consumers to stay informed and take necessary precautions to ensure their health and safety.