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 fo

FDA recall notice · announced May 1, 2024 · Cipla

Class II FDA/FSIS Class II: use may cause temporary or medically reversible adverse health consequences.

The 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

Reason for recall

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

Notes

Distribution: USA nationwide.
Lot/code information: Lot # IA30390, Exp 4/30/2025, IA30517, Exp 6/30/ 2025
Quantity: 59244/3ml FFS packs
Status: Terminated
Products in this recall event:
- 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: Ci (D-0471-2024)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.