Ascend Laboratories recalls 360 mg Mycophenolic Acid Delayed-Release Tablets due to failed dissolution specifications. This may affect medication effectiveness. Check NDC 67877-427-12 and lot numbers for affected batches.
Failed Dissolution Specifications
Ascend Laboratories is recalling Mycophenolic Acid Delayed-Release Tablets (360 mg, 120 tablets per bottle) because they failed dissolution specifications. This could mean the medication doesn't work as intended, which is serious for patients needing immunosuppressants.
The tablets failed to dissolve properly as intended, which could lead to inconsistent medication levels in the body. This might reduce effectiveness for patients who rely on the drug to prevent organ rejection after transplantation.
Patients prescribed Mycophenolic Acid for conditions like organ transplants are most at risk. The recall affects specific batches manufactured by Alkem Laboratories in India and distributed by Ascend Laboratories.
Check for the NDC code 67877-427-12 on the bottle. Affected lots include 22123437-22123538, 23120529-23120705, and others with specific expiration dates listed in the recall notice.
Look for the NDC code 67877-427-12 and lot numbers listed in the recall notice to confirm if your tablets are affected.
The tablets failed dissolution specifications, which could mean they don't work as intended for patients needing immunosuppressants.
The recall does not specify a stop-use instruction; affected batches should be checked against the listed lot numbers.
Check the NDC code 67877-427-12 and lot numbers from the recall notice, which include specific batches with dates like 22123437 through 23122331.
We’ve drafted a message you can send Ascend Laboratories to request your refund or repair — edit it as you like.
Subject: Recall D-0668-2024 — Ascend Laboratories Ascend Laboratories Hello, I own a Ascend Laboratories that is covered by recall D-0668-2024 from Ascend Laboratories. 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.