Reported Oct 5, 2022 · Terminated

Budesonide Inhalation Suspension 0.25mg/2mL, For Inhalation Only, Rx Only, 1 envelope x five 2 mL Single Dose Ampules…

Cipla

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: CIPLA · 10 Independence Blvd · Warren, NJ · 07059-2730

Is this the product you have?

  • Budesonide Inhalation Suspension 0.25mg/2mL, For Inhalation Only, Rx Only, 1 envelope x five 2 mL Single Dose Ampules per pouch, Sterile Suspension
  • Manufactured byCipla Ltd., India, Manufactured for Cipla USA Inc., Warren NJ, NDC# 69097-318-86
Lot codes and dates
    • Lot #s: GA20080
    • GA20081
    • GA20094
    • Exp. 01/2024
Amount recalled
641,160 ampules

Where it was sold

  • Nationwide
  • PR

Why it was recalled

Lack of Assurance of Sterility

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA drug enforcement) notice

Notice updated Jan 10, 2024 · Data as of Sep 19, 8:04 PM UTC

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