Cipla recalls certain batches of Arformoterol Tartrate Inhalation Solution due to environmental monitoring failure causing lack of sterility. This could lead to infections if used.
Lack of Assurance of Sterility: environmental monitoring failure.
Cipla is recalling specific batches of Arformoterol Tartrate Inhalation Solution vials because of a lack of sterility. This means the product could cause infections if used, so affected users should stop using it.
The product was manufactured in a facility where environmental monitoring failed, leading to a lack of sterility. This means the inhaler could contain harmful bacteria or other contaminants that could cause infections when inhaled.
People with prescriptions for Arformoterol Tartrate Inhalation Solution who received the recalled batches (NDC 69097-168-48 or 69097-168-64) are affected. Those using the product for respiratory conditions are at highest risk.
Check the product label for the NDC codes 69097-168-48 or 69097-168-64. The vials were packaged in 5 x 2 mL vials per pouch and 12 x 5 vials per carton, with batch numbers IA10082-IA10086 (expiring 01/2023) or IA10122-IA10130 (expiring 02/2023).
Immediately stop using the recalled Arformoterol Tartrate Inhalation Solution vials as they may contain contaminants that could cause infections.
Batches IA10082-IA10086 (expiring 01/2023) and IA10122-IA10130 (expiring 02/2023) with NDC codes 69097-168-48 or 69097-168-64.
Check the product label for the NDC codes 69097-168-48 or 69097-168-64, and look for batch numbers IA10082-IA10086 or IA10122-IA10130.
The recall record does not mention any replacement or remedy.
We’ve drafted a message you can send Cipla to request your refund or repair — edit it as you like.
Subject: Recall D-1550-2022 — Cipla Cipla Hello, I own a Cipla that is covered by recall D-1550-2022 from Cipla. 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.
