FDAFDA · Food and drugs·Recall number D-0161-2024
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
Published January 3, 2024 · Recall initiated: January 26, 2022
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Brand
- IPRATROPIUM BROMIDE AND ALBUTEROL SULFATE
- Manufacturer
- CARDINAL HEALTHCARE
- Distributor
- Nationwide USA
- Lot
- Batch 21C56
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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