Apotex recalls 10mg leflunomide tablets (30-count and 1000-count bottles) due to subpotent quality. These prescription drugs may not meet strength specifications.
Subpotent (Single Ingredient Drug): Distribution of product that did not meet specifications.
Apotex is recalling 10mg leflunomide tablets in 30-count and 1000-count bottles because they did not meet the required strength specifications. This could affect the drug's effectiveness for patients using it for autoimmune conditions.
The tablets did not meet the required strength specifications. This means the medication might not work as intended for patients who need it for conditions like rheumatoid arthritis.
Prescription patients using Apotex leflunomide tablets. Those with autoimmune conditions like rheumatoid arthritis may be most affected.
Check for Apotex brand tablets labeled 10mg leflunomide. The 30-count bottle has NDC 60505-2502-1 and the 1000-count bottle has NDC 60505-2502-3. These are prescription-only products.
Look for the NDC codes 60505-2502-1 (30-count) or 60505-2502-3 (1000-count) on the bottle.
The tablets did not meet the required strength specifications, which could affect their effectiveness for patients using them for autoimmune conditions.
Check for Apotex leflunomide tablets with NDC codes 60505-2502-1 (30-count) or 60505-2502-3 (1000-count). These are prescription-only products.
The recall does not specify a remedy, so contact your doctor or pharmacist for guidance.
We’ve drafted a message you can send Apotex to request your refund or repair — edit it as you like.
Subject: Recall D-1661-2012 — Apotex Apotex Hello, I own a Apotex that is covered by recall D-1661-2012 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.
