CARDINAL HEALTHCARE: Drug Recall

Recall #D-0161-2024 · 01/26/2022

Class II: Risk

Recall Details

Recall Number
D-0161-2024
Classification
Class II
Product Type
Drug
Recalling Firm
CARDINAL HEALTHCARE
Status
Terminated
Date Initiated
01/26/2022
Location
Dublin, OH, United States
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
2 cartons

Reason for Recall

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

Product Description

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

Distribution Pattern

Nationwide USA

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.