Apotex recalls 30mg Paroxetine Hydrochloride tablets (NDC 60505-0084-1, 60505-0084-2, 60505-0084-4) due to impurities. These prescription antidepressants may have unsafe chemical levels that could cause harm.
Failed Impurities/Degradation Specifications-Out of specification (OOS) results for the excipient Amadori Glucose adduct of Paroxetine
Apotex is recalling certain 30mg Paroxetine Hydrochloride tablets (prescription antidepressants) because testing found unsafe chemical levels. This could potentially cause harm to users, though the exact risk is not specified in the recall.
The tablets failed quality tests for impurities, specifically an unsafe chemical compound called Amadori Glucose adduct. This could potentially cause harm to users, though the exact risk level isn't specified in the recall notice.
Prescription antidepressant users who have the specific Apotex Paroxetine tablets with the listed NDC numbers. People taking this medication for depression or anxiety are most at risk.
Check for the specific NDC numbers: 60505-0084-1 (30-count), 60505-0084-2 (100-count), or 60505-0084-4 (1000-count). These are prescription antidepressants sold by Apotex Corp. in the US.
Look for the NDC numbers 60505-0084-1, 60505-0084-2, or 60505-0084-4 on the bottle label to identify affected tablets.
The recall states that the tablets failed quality tests for impurities, but does not specify if they are safe to take. You should not use these specific tablets until the recall is resolved.
The recall does not provide a specific remedy, so you should contact Apotex directly for guidance on what to do with the affected tablets.
The recall mentions failed impurities tests, but does not specify the exact risks. You should not use these tablets until the recall is resolved.
We’ve drafted a message you can send Apotex to request your refund or repair — edit it as you like.
Subject: Recall D-0121-2024 — Apotex Apotex Hello, I own a Apotex that is covered by recall D-0121-2024 from Apotex. 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.
