Glenmark Pharmaceuticals recalls 500-count potassium chloride capsules due to CGMP deviations. Affected lots expire through 2025. Consumers should check NDC 68462-357-05 and lot numbers for recall.
CGMP Deviations
Glenmark Pharmaceuticals is recalling potassium chloride extended-release capsules because of manufacturing quality control issues. This recall affects specific batches that may have been produced with deviations from standard safety practices. The issue could potentially lead to improper medication dosing if the capsules are not manufactured correctly.
CGMP deviations refer to failures in the manufacturing process that could result in the medication not being produced to the required quality standards. This might lead to incorrect dosing or ineffective treatment if the capsules do not meet the intended specifications.
Prescription patients who have the specific 500-count bottle of potassium chloride capsules with the listed lot numbers and expiration dates are affected. Patients using this medication for medical conditions like low potassium levels are most at risk.
Check the product label for NDC 68462-357-05 and lot numbers listed in the recall notice. The capsules are prescription-only and come in a 500-count bottle. The affected lots have specific expiration dates through 2025.
Look for NDC 68462-357-05 and lot numbers 17230186 through 17232119 on the bottle.
The recall is due to CGMP deviations, which are manufacturing quality control issues that could affect the medication's safety and effectiveness.
Check the product label for the NDC 68462-357-05 and lot numbers listed in the recall notice. If you have the affected product, contact your doctor or pharmacist for guidance.
The recall is due to potential manufacturing issues that could lead to incorrect dosing or ineffective treatment, but the specific safety risks are not detailed in the official notice.
We’ve drafted a message you can send Glenmark to request your refund or repair — edit it as you like.
Subject: Recall D-0607-2024 — Glenmark Glenmark Hello, I own a Glenmark that is covered by recall D-0607-2024 from Glenmark. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
