Recalls / Class II
Class IID-0471-2024
Product
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
- Brand name
- Ipratropium Bromide And Albuterol Sulfate
- Generic name
- Ipratropium Bromide And Albuterol Sulfate
- Active ingredients
- Albuterol Sulfate, Ipratropium Bromide
- Route
- Respiratory (inhalation)
- NDC
- 69097-173
- FDA application
- ANDA077559
- Affected lot / code info
- Lot # IA30390, Exp 4/30/2025, IA30517, Exp 6/30/ 2025
Why it was recalled
Short fill: Complaints received of less fill volume in respule and few drops of liquid observed in the intact pouch.
Recalling firm
- Firm
- Cipla USA, Inc.
- Manufacturer
- Cipla USA Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 10 Independence Blvd, N/A, Warren, New Jersey 07059-2730
Distribution
- Quantity
- 59244/3ml FFS packs
- Distribution pattern
- USA nationwide.
Timeline
- Recall initiated
- 2024-03-26
- FDA classified
- 2024-04-24
- Posted by FDA
- 2024-05-01
- Terminated
- 2025-07-09
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0471-2024. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.