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: GA20080GA20081GA20094Exp. 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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