Why it was recalled
Short fill: Complaints received of less fill volume in respule and few drops of liquid observed in the intact pouch.
Product description
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
Lot numbers, UPCs & expiration codes
Lot # IA30390, Exp 4/30/2025, IA30517, Exp 6/30/ 2025
Where it was sold
USA nationwide.
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0471-2024
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Mar 26, 2024
- FDA report date
- May 1, 2024
- Quantity
- 59244/3ml FFS packs
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Cipla USA, Inc.
Original FDA data
Every field from FDA enforcement report D-0471-2024, exactly as published.
Show all FDA fields
- City
- Warren
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 94289
- Address
- 10 Independence Blvd
- Code information
- Lot # IA30390, Exp 4/30/2025, IA30517, Exp 6/30/ 2025
- Postal code
- 07059-2730
- Report date
- May 1, 2024
- Product type
- Drugs
- Recall number
- D-0471-2024
- Classification
- Class II
- Recalling firm
- Cipla USA, Inc.
- Product quantity
- 59244/3ml FFS packs
- Termination date
- Jul 9, 2025
- Reason for recall
- Short fill: Complaints received of less fill volume in respule and few drops of liquid observed in the intact pouch.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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
- Distribution pattern
- USA nationwide.
- Recall initiation date
- Mar 26, 2024
- Initial firm notification
- Letter
- Center classification date
- Apr 24, 2024