D-0161-2024 Class II Terminated
FDA drug recall D-0161-2024 was initiated by CARDINAL HEALTHCARE on Jan 26, 2022 and is designated Class II. Reason for recall: CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions. The recall status is terminated (terminated Sep 29, 2024). Affected quantity: 2 cartons.
Recall Details
- Product Type
- Drugs
- Report Date
- Jan 3, 2024
- Initiation Date
- Jan 26, 2022
- Termination Date
- Sep 29, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 2 cartons
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
Reason for Recall
CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
Distribution Pattern
Nationwide USA
Code Information
Batch 21C56
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0161-2024
- openFDA file date
- Oct 26, 2026
- Loaded by RegDataLab
- Oct 27, 2026