Reported May 1, 2024 · Terminated
Ipratropium Bromide and Albuterol Sulfate Inhalation Solution USP, 0.5 mg & 3mg/3mL unit-dose vials, packaged in carton…
Cipla USA, Inc.
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 USA, Inc. · 10 Independence Blvd · Warren, NJ · 07059-2730
Is this the product you have?
- 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 byCipla Ltd., Indore SEZ, Pithampur, India
- Manufactured forCipla USA, Inc., 10 Independence Boulevard, Suite 300, Warren, NJ 07059, NDC 69097-173-53
- Lot codes and dates
Lot # IA30390Exp 4/30/2025IA30517Exp 6/30/ 2025
- Amount recalled
- 59244/3ml FFS packs
Where it was sold
- Nationwide
Why it was recalled
Short fill: Complaints received of less fill volume in respule and few drops of liquid observed in the intact pouch.
This product could cause temporary or reversible health problems — stop using it.
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