Glenmark Pharmaceuticals recalls 10mg rizatriptan benzoate tablets due to N-nitroso desmethyl rizatriptan impurity exceeding FDA limits. Affected lots from 19224217 to 19224444 with expiration dates through 9/2024.
CGMP Deviations: N-Nitroso Desmethyl Rizatriptan Impurity results that are above the FDA acceptable limit.
Glenmark is recalling 10mg rizatriptan benzoate tablets that contain an impurity above FDA safety limits. This could pose a health risk if taken as directed.
The tablets contain an impurity called N-nitroso desmethyl rizatriptan that exceeds the FDA's acceptable limit. This impurity could potentially cause health issues if the medication is taken as directed.
People who have the specific lot numbers of 10mg rizatriptan benzoate tablets from Glenmark Pharmaceuticals. Those with the product may be at risk if the impurity exceeds safe levels.
Check the lot number on the tablet packaging, which is listed as 19224217, 19233789, or 19224444. The expiration dates for these lots are September 2024 or September 2025.
Look for the lot number on the tablet packaging: 19224217, 19233789, or 19224444.
The tablets contain N-nitroso desmethyl rizatriptan, an impurity that exceeds the FDA's acceptable limit.
Check the lot number on the packaging: 19224217, 19233789, or 19224444.
The recall does not specify a stop-use instruction, but you should check the lot number to determine if your product is affected.
We’ve drafted a message you can send Glenmark to request your refund or repair — edit it as you like.
Subject: Recall D-0533-2024 — Glenmark Glenmark Hello, I own a Glenmark that is covered by recall D-0533-2024 from Glenmark. 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.
