Major Pharmaceuticals recalls 37.5mg Venlafaxine Hydrochloride extended-release capsules due to failed dissolution testing during stability checks. This medication is prescription-only and may not release properly in the body.
Failed dissolution specifications: out of specification result obtained during routine stability testing for high dissolution.
Major Pharmaceuticals is recalling 37.5mg Venlafaxine Hydrochloride extended-release capsules because they failed dissolution testing during routine stability checks. This means the capsules might not release medication properly in the body, potentially affecting treatment effectiveness.
The capsules failed dissolution testing during routine stability checks, meaning they may not release medication properly in the body. This could affect how well the medication works for patients who need it for mental health conditions.
Prescription patients who received this specific 37.5mg Venlafaxine Hydrochloride extended-release capsule product from Major Pharmaceuticals. Those with mental health conditions requiring this medication are most at risk.
Look for the product labeled 'Venlafaxine Hydrochloride, extended-release capsules, USP, 37.5mg, 10 x 10 blister card in one carton, Rx only'. The NDC code is 0904-7075-61 and it was manufactured with lot code M04614, expiring September 30, 2024.
Verify the NDC code 0904-7075-61 and lot code M04614 on the packaging to confirm if this product is affected.
The recall is due to failed dissolution testing, but the product is still safe to use if it hasn't expired. Consult your doctor for advice on whether to continue using it.
Check for the NDC code 0904-7075-61 and lot code M04614 on the packaging. The product expires September 30, 2024.
The recall does not require immediate action. Check the product details and consult your doctor to determine if you should continue using it.
We’ve drafted a message you can send Major Pharmaceuticals to request your refund or repair — edit it as you like.
Subject: Recall D-0584-2024 — Major Pharmaceuticals Major Pharmaceuticals Hello, I own a Major Pharmaceuticals that is covered by recall D-0584-2024 from Major Pharmaceuticals. 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.
