FDA-Drug2022-10-12Class II
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.
CIPLA
Hazard
Lack of Assurance of Sterility: environmental monitoring failure.
Sold states
Product was distributed nationwide to distributors/wholesalers who may have further distributed the product.
Affected count
9041 cartons
Manufactured in
10 Independence Blvd, N/A, Warren, NJ, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1550-2022Don't want to check this manually?
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