Safety Alert: Potassium
Recall on All ETHEX Brand Potassium Chloride Capsules and Tablets
The ETHEX Corporation, a subsidiary of KV Pharmaceutical, has recalled all lots of ETHEX brand potassium chloride extended release capsules and tablets. These recalled capsules and tablets may have been manufactured under conditions that did not meet the current manufacturing standards called Good Manufacturing Practices (cGMPs). Some ETHEX products have recently had specific lots recalled due to defects found, including oversized tablets. ETHEX is now recalling all of their products to ensure that no other defective products remain available to patients.
The ETHEX capsules and tablets and the NDC numbers involved in the recall are listed below. The NDC number is a product number that is sometimes listed on a prescription label.
Potassium Chloride ER Capsules, 8mEq (NDC 58177-677-04 & NDC 58177-677-08)
Potassium Chloride ER Capsules, 10mEq (NDC 58177-001-04, NDC 58177-001-08, NDC 58177-001-09, & NDC 58177-001-11)
Potassium Chloride ER Tablets, 20mEq (NDC 58177-202-04, NDC 58177-202-08, NDC 58177-202-09 & NDC 58177-202-11)
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What does this mean?
If you are taking potassium, look at your prescription to see if it is labeled with the generic name "Potassium Chloride ER" (8mEq, 10mEq, or 20 mEq) and if it was manufactured by ETHEX Corporation. The manufacturer is often listed on the prescription label. If you are taking potassium chloride ER and think your capsules or tablets are involved in the recall, or if you are unsure, take your bottle to your pharmacy for your pharmacist to check. Most pharmacies will provide you with replacement medicine if your medicine is involved in the recall and you return your original bottle.
At this time, this recall has not been associated with any health problems. If you are using medicine covered by this recall you should continue to take it as directed until you speak with your pharmacist - suddenly stopping your medicine may place you at a greater risk for problems.
If you have any questions or concerns about this alert or your potassium, please follow up with your doctor or pharmacist.
