Direct Rx recalls Losartan Pot/HCTZ 100/12.5 mg 90-tab tablets (NDC 72189-290-90) due to AZIDO impurity levels exceeding safety limits. Affected lots manufactured by Macleods Pharma USA, Inc. in Plainsboro, NJ.
CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits .
Direct Rx is recalling Losartan Pot/HCTZ 100/12.5 mg tablets because they contain AZIDO impurities at levels above acceptable safety limits. This could pose a health risk if taken by users.
The recall is due to AZIDO impurities being detected in the medication at levels that exceed the acceptable safety limits. This could potentially cause health issues if the medication is taken as directed.
People who purchased or have the Losartan Pot/HCTZ 100/12.5 mg 90-tab tablets (NDC 72189-290-90) from Direct Rx in the U.S. are affected. Those with the specific lot number (25OC2116) produced by Macleods Pharma USA, Inc. are at highest risk.
Check for the product name 'Losartan Pot/HCTZ 100/12.5 mg 90 Tabs' with NDC code 72189-290-90. The lot number 25OC2116 was produced by Macleods Pharma USA, Inc. in Plainsboro, NJ.
Verify the product name, NDC code, and lot number to confirm if your medication is affected.
The recall states AZIDO impurities were found at levels above acceptable limits, which could pose a health risk if taken. However, the official notice does not specify the exact health risks.
Check for the product name 'Losartan Pot/HCTZ 100/12.5 mg 90 Tabs' with NDC 72189-290-90 and lot number 25OC2116.
The recall does not specify a remedy, so you should contact Direct Rx or your healthcare provider for guidance.
We’ve drafted a message you can send Direct Rx to request your refund or repair — edit it as you like.
Subject: Recall D-0893-2022 — Direct Rx Direct Rx Hello, I own a Direct Rx that is covered by recall D-0893-2022 from Direct Rx. 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.
