Arformoterol Tartrate Inhalation Solution recalled over sterility concerns

Recall date

September 29, 2022

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

CIPLA recalls Arformoterol Tartrate Inhalation Solution, 15 mcg/2mL, 2 mL Sterile Unit-Dose Vial packaged in 5 x 2 mL Sterile Unit-Do…

Recall number

D-1550-2022

FDA classification

Class II

Brand / firm

CIPLA

Sold / distributed

Product was distributed nationwide to distributors/wholesalers who may have further distributed the product.

Why it was recalled

Lack of Assurance of Sterility: environmental monitoring failure.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.