FDAFDA · Food and drugs·Recall number D-1550-2022
Arformoterol Tartrate Inhalation Solution, 15 mcg/2mL, 2 mL Sterile Unit-Dose Vial packaged in 5 x 2 mL Sterile Unit-Dose Vials per pouch, NDC 69097-168-48; 60 (12 x 5) x 2 mL Sterile Unit-Dose Vials per carton, NDC 69097-168-64, Rx Only, Manufactured by: Cipla Ltd., Indore SEZ, Pithampur, India; Manufactured for: Cipla USA, Inc., 10 Independence Boulevard, Suite 300, Warren, NJ 07059.
Published October 12, 2022 · Recall initiated: September 29, 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
Lack of Assurance of Sterility: environmental monitoring failure.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Brand
- ARFORMOTEROL TARTRATE
- Manufacturer
- CIPLA
- Distributor
- Product was distributed nationwide to distributors/wholesalers who may have further distributed the product.
- Lot
- Batch No: IA10082, IA10083, IA10084, IA10085, IA10086, exp. date 01/2023; IA10122, IA10123, IA10124, IA10125, IA10126, IA10127, IA10128, IA10129, IA10130, exp. date 02/2023
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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