Glenmark Recall 114 Batches of Potassium Chloride Capsules in US

Glenmark Pharmaceuticals is recalling 114 batches of Potassium Chloride Extended-Release Capsules, USP (750 mg) 10 mEq K due to failed dissolution. Following this, there was one more recall  of 21 batches of Potassium Chloride Capsules by American Health Packaging on behalf of BluePoint Laboratories. Both products are covered by same ANDA (202868) and manufactured at Glenmark facility at Pithampur, India.

As per the Product label, Potassium chloride extended-release capsules, USP, 10 mEq is an oral dosage form of microencapsulated potassium chloride containing 750 mg of potassium chloride USP equivalent to 10 mEq of potassium. The controlled release of K+ ions by the microcapcular membrane over 8-10 hours is intended to avoid excessive amounts of KCl (Potassium chloride) localised in the gastrointestinal tract. Potassium chloride extended-release capsules, USP, 10 mEq are electrolyte replenishers.

Potassium Chloride Extended-Release Capsules are indicated for the treatment of patients with hypokalemia. The failed dissolution of potassium chloride extended release capsules may cause high serum potassium levels, also known as hyperkalemia, which can result in irregular heart beat that can lead to cardiac arrest. Glenmark has not received any reports of hyperkalemia or serious adverse events related to this recall.

Recall Announcement – Glenmark

Recall Announcement  – American Health Packaging