Cipla recalls 0.5 mg & 3mg/3mL inhalation solution vials due to reported short fill volume and few drops in pouches. Affected units may have less medication than labeled.
Short fill: Complaints received of less fill volume in respule and few drops of liquid observed in the intact pouch.
Cipla is recalling inhalation solution vials that may contain less medication than labeled. This could mean patients receive a lower dose than intended, potentially affecting treatment effectiveness.
The product may have less medication than labeled due to short fill volume in the vial and few drops observed in the pouch. This could lead to patients receiving a lower dose than intended, potentially reducing treatment effectiveness.
Patients prescribed this inhalation solution by a doctor are affected. Those using the product for asthma or COPD treatment may be at risk if the dose is insufficient.
Check for vials labeled 'Ipratropium Bromide and Albuterol Sulfate Inhalation Solution USP, 0.5 mg & 3mg/3mL' in cartons with 30 vials (6 pouches of 5 vials). The product was manufactured by Cipla Ltd. in India and distributed by Cipla USA, Inc. in the US.
Look for the product name and NDC number 69097-173-53 on the carton.
The recall is due to potential short fill volume, but the product is still safe to use if the dose is sufficient. Consult your doctor for guidance.
Check for vials labeled 'Ipratropium Bromide and Albuterol Sulfate Inhalation Solution USP, 0.5 mg & 3mg/3mL' in cartons with 30 vials (6 pouches of 5 vials).
The recall does not specify a remedy, so contact your doctor or pharmacist for advice on whether to continue using the product.
We’ve drafted a message you can send Cipla to request your refund or repair — edit it as you like.
Subject: Recall D-0471-2024 — Cipla Cipla Hello, I own a Cipla that is covered by recall D-0471-2024 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.
