Glenmark recalls Arformoterol Tartrate Inhalation Solution 15 mcg/2mL due to lack of assurance of sterility. This could lead to infections if used.
Lack of Assurance of Sterility
Glenmark is recalling Arformoterol Tartrate Inhalation Solution 15 mcg/2 mL vials because they may not be sterile. Using these vials could lead to infections, so affected users should stop using them immediately.
The product may not be sterile, which means it could cause infections if used. This is a serious risk because the inhaler is for medical use and infections can be severe for people with respiratory conditions.
People with prescriptions for Arformoterol Tartrate Inhalation Solution 15 mcg/2 mL from Glenmark. Those with the specific vial lots and expiration dates listed are most at risk.
Check for vials labeled 'Arformoterol Tartrate Inhalation Solution 15 mcg/2 mL' with NDC numbers 68462-833-65 or 68462-833-35. The affected lots have specific expiration dates listed in the recall.
Immediately stop using the recalled vials as they may not be sterile and could cause infections.
Arformoterol Tartrate Inhalation Solution 15 mcg/2 mL for oral inhalation only.
Vials with NDC numbers 68462-833-65 or 68462-833-35, and specific lots with expiration dates listed in the recall.
Check the NDC number and expiration date on the vial. Affected vials have the NDC numbers and expiration dates listed in the recall notice.
We’ve drafted a message you can send Glenmark to request your refund or repair — edit it as you like.
Subject: Recall D-0827-2021 — Glenmark Glenmark Hello, I own a Glenmark that is covered by recall D-0827-2021 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.
