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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 numberBatch 21C56
Where it was soldNationwide USA
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

CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.

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 byThe Ritedose Corporation, Columbia, SC 29203; Distributed By: Cipla USA Inc., 10 Independence Boulevard, Suite 300, Warren, NJ 07059
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
NDC69097-840-64
Show the full FDA record
Full product labelIpratropium Bromide and Albuterol Sulfate Inhalation Solution (0.5 mg/3 mg per 3 mL), 60 x 3 mL Sterile Unit-Dose Vials (2 pouches of 30 - 3 mL vials each), Manufactured By: The Ritedose Corporation, Columbia, SC 29203; Distributed By: Cipla USA Inc., 10 Independence Boulevard, Suite 300, Warren, NJ 07059. NDC: 69097-840-64
Recalling firmCARDINAL HEALTHCARE
DistributionNationwide USA
Quantity2 cartons
Recall initiated2022-01-26
Report date2024-01-03
Recall completed2024-09-29
Recall numberD-0161-2024
ClassificationClass II
FDA statusTerminated
Origin on fileDublin OH United States

Related

Albuterol recallsRecent drug recallsCheck another medication

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.