Status
Terminated
Drug Enforcement D-0161-2024
CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
Classification
Class II
Report Date
January 3, 2024
Termination Date
September 29, 2024
Product Information
- 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
- Product quantity
- 2 cartons
- Reason for recall
- CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
- Recall initiation reason
- —
- Initial firm notification
- Letter
- Distribution pattern
- Nationwide USA
Location & Firm
- Recalling firm
- CARDINAL HEALTHCARE
- Address
-
7200 Cardinal Pl W
United States - Voluntary / Mandated
- Voluntary: Firm initiated
- Status date
- —
Codes & Dates
- Recall number
- D-0161-2024
- Event ID
- 89450
- Recall initiation date
- January 26, 2022
- Center classification date
- December 26, 2023
- Code info
- Batch 21C56
- More code info
- —