Apotex recalls 10 mg Paroxetine Hydrochloride Tablets due to failed impurities testing. These tablets could pose health risks if used as directed. Consumers should contact Apotex for details.
Failed Impurities/Degradation Specifications-Out of specification (OOS) results for the excipient Amadori Glucose adduct of Paroxetine
Apotex is recalling 10 mg Paroxetine Hydrochloride Tablets that failed impurities testing. This could pose health risks if taken as directed, though the specific danger isn't detailed in the recall notice.
The tablets failed impurities testing, specifically for an Amadori Glucose adduct of Paroxetine. This could mean the tablets contain harmful substances that might cause health issues if taken as directed.
People who have the recalled Paroxetine Hydrochloride Tablets (10 mg, 30-count or 100-count bottles) may be affected. Those taking this medication for mental health conditions are most at risk.
Check for the brand Apotex and product name Paroxetine Hydrochloride Tablets USP, 10 mg. The recalled items have NDC numbers 60505-0097-1 (30-count), 60505-0097-2 (100-count), and 60505-0097-4 (1000-count).
Identify the NDC numbers: 60505-0097-1 (30-count), 60505-0097-2 (100-count), or 60505-0097-4 (1000-count).
The recall states the tablets failed impurities testing, but does not specify if they are safe to take. Consumers should not use them until the recall is resolved.
The recall does not provide specific instructions for what to do with the tablets. Contact Apotex for guidance.
Check the NDC numbers: 60505-0097-1 (30-count), 60505-0097-2 (100-count), or 60505-0097-4 (1000-count).
We’ve drafted a message you can send Apotex to request your refund or repair — edit it as you like.
Subject: Recall D-0119-2024 — Apotex Apotex Hello, I own a Apotex that is covered by recall D-0119-2024 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.
