Class IITerminated

Ipratropium Bromide and Albuterol Sulfate Inhalation Solution USP recall

FDA recall D-0471-2024 · initiated Mar 26, 2024

May cause temporary or medically reversible harm; low probability of serious harm.

Why it was recalled

Short fill: Complaints received of less fill volume in respule and few drops of liquid observed in the intact pouch.

Details

Product: Ipratropium Bromide and Albuterol Sulfate Inhalation Solution USP, 0.5 mg & 3mg/3mL unit-dose vials, packaged in carton containing 30 vials ( 6 pouches of 5 - 3 mL vials), Rx only, Manufactured by: Cipla Ltd., Indore SEZ, Pithampur, India, Manufactured for: Cipla USA, Inc., 10 Independence Boulevard, Suite 300, Warren, NJ 07059, NDC 69097-173-53
Recalling company: Cipla Limited
Classification: Class II
Status: Terminated
Type: Voluntary: Firm initiated
Distribution: USA nationwide.
Initiated: Mar 26, 2024
FDA report date: May 1, 2024

What to do.If you have a recalled product, don't throw away questions — check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This page reproduces public FDA data and is not medical advice.

Source: openFDA Drug Enforcement record D-0471-2024 ↗

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