Macleods Pharma recalls 30-count, 90-count, and 1000-count Losartan Potassium & Hydrochlorothiazide Tablets due to AZIDO impurity levels exceeding safety limits. Consumers should not use these products.
CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits
Macleods Pharma is recalling certain Losartan Potassium & Hydrochlorothiazide Tablets because they contain AZIDO impurities at levels above acceptable safety limits. This could pose a health risk to users, especially those taking the medication regularly.
The tablets contain AZIDO impurities at levels that exceed the acceptable limits set by regulatory standards. This impurity could potentially cause health issues, especially for people who take the medication regularly.
People who have the recalled 30-count, 90-count, or 1000-count bottles of Losartan Potassium & Hydrochlorothiazide Tablets (NDC numbers listed) are affected. Those taking this medication for blood pressure or other conditions are most at risk.
Check for the product name 'Losartan Potassium & Hydrochlorothiazide Tablets, USP, 100 mg/12.5 mg' in 30-count, 90-count, or 1000-count bottles. The NDC numbers are 33342-051-07, 33342-051-10, and 33342-051-44.
Immediately stop using the recalled tablets as they contain AZIDO impurities that could pose a health risk.
The recall is due to AZIDO impurities in the tablets, which were found at levels above acceptable limits.
The affected NDC numbers are 33342-051-07 (30-count), 33342-051-10 (90-count), and 33342-051-44 (1000-count).
Check the product label for the NDC numbers listed: 33342-051-07, 33342-051-10, or 33342-051-44.
We’ve drafted a message you can send Macleods Pharma to request your refund or repair — edit it as you like.
Subject: Recall D-0837-2022 — Macleods Pharma Macleods Pharma Hello, I own a Macleods Pharma that is covered by recall D-0837-2022 from Macleods Pharma. 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.
