FDA-Drug2024-01-03Class II

Ipratropium 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

CARDINAL HEALTHCARE
Hazard

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

Sold states
Nationwide USA
Affected count
2 cartons
Manufactured in
7200 Cardinal Pl W, Dublin, OH, United States
Products
Ipratropium 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

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0161-2024

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