FDAFDA · Food and drugs·Recall number D-0471-2024
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 by: Cipla Ltd., Indore SEZ, Pithampur, India, Manufactured for: Cipla USA, Inc., 10 Independence Boulevard, Suite 300, Warren, NJ 07059, NDC 69097-173-53
Published May 1, 2024 · Recall initiated: March 26, 2024
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Short fill: Complaints received of less fill volume in respule and few drops of liquid observed in the intact pouch.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Brand
- IPRATROPIUM BROMIDE AND ALBUTEROL SULFATE
- Manufacturer
- Cipla USA, Inc.
- Distributor
- USA nationwide.
- Lot
- Lot # IA30390, Exp 4/30/2025, IA30517, Exp 6/30/ 2025
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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