Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Arformoterol Tartrate Inhalation Solution Recalled by CIPLA Due to Lack of Assurance of Sterility: environmental monitoring failure.
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact CIPLA directly.
Affected 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.
Quantity: 9041 cartons
Why Was This Recalled?
Lack of Assurance of Sterility: environmental monitoring failure.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About CIPLA
CIPLA has 11 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report