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Class II · ModerateRecall completed

Ipratropium Bromide And Albuterol Sulfate

Could cause temporary or reversible harm; serious harm is unlikely.

Does this affect you?
Check your lot numberLot # IA30390, Exp 4/30/2025, IA30517, Exp 6/30/ 2025
Where it was soldUSA nationwide.
Find the lot number printed on your box or bottle. If it matches — and you take this medicine — call your pharmacist. Don't stop a prescribed medicine on your own.

What happened

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

What to do

  1. Check the lot number and expiry on your medicine against the recall above.
  2. Talk to your pharmacist or doctor before changing anything — don't stop on your own.
  3. Report any problems to FDA MedWatch (1-800-FDA-1088 or fda.gov/medwatch).

Who makes it

Made byCipla Ltd., Indore SEZ, Pithampur, India, Manufactured for: Cipla USA, Inc., 10 Independence Boulevard, Suite 300, Warren, NJ 07059 foreign manufacturer
Brand nameIPRATROPIUM BROMIDE AND ALBUTEROL SULFATE
Generic nameIPRATROPIUM BROMIDE AND ALBUTEROL SULFATE
Active ingredient(s)ALBUTEROL SULFATE, IPRATROPIUM BROMIDE
Distributed by / forCipla USA, Inc., 10 Independence Boulevard, Suite 300, Warren, NJ 07059
NDC69097-173-53
Show the full FDA record
Full product labelIpratropium 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 firmCipla USA, Inc.
DistributionUSA nationwide.
Quantity59244/3ml FFS packs
Recall initiated2024-03-26
Report date2024-05-01
Recall completed2025-07-09
Recall numberD-0471-2024
ClassificationClass II
FDA statusTerminated
Origin on fileWarren NJ United States

Related

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Source: U.S. FDA enforcement database (openFDA). Look this up on the official FDA recalls site ↗

This is public FDA recall information, not medical advice. A recall does not always mean your specific bottle is affected. Never stop a prescribed medicine without asking your pharmacist or doctor.