Ascend Laboratories recalls Fosfomycin Tromethamine Granules for Oral Solution due to impurities detected after 6 months of storage. Affected lots from June 2024 to September 2024. No remedy specified.
Failed Impurities/Degradation Specifications: Out-of-specification results observed for the organic impurities test at 6 months, RT Stability.
Ascend Laboratories is recalling Fosfomycin Tromethamine Granules for Oral Solution because tests found impurities after 6 months of storage. This could lead to unsafe drug levels if used beyond the expiration date.
The drug showed impurities in tests after 6 months of storage at room temperature. This could mean the medication has unsafe levels of substances that might affect health if taken.
Prescription patients who received the recalled Fosfomycin granules from June 2024 to September 2024. Those with the specific lot numbers are most at risk.
Check the product label for the lot numbers listed: 22121970 through 22123330. The expiration dates range from June 2024 to September 2024.
Look for the lot numbers listed in the recall notice: 22121970 through 22123330.
The official notice does not specify a remedy.
Lot numbers 22121970 through 22123330, expiring June 2024 to September 2024.
The issue was detected after 6 months of storage at room temperature.
We’ve drafted a message you can send Ascend Laboratories to request your refund or repair — edit it as you like.
Subject: Recall D-1145-2023 — Ascend Laboratories Ascend Laboratories Hello, I own a Ascend Laboratories that is covered by recall D-1145-2023 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.