FDA recall D-1550-2022

Product

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.

Reason for recall

Lack of Assurance of Sterility: environmental monitoring failure.

Distribution

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

Key facts

Status

Terminated

Initiation date

2022-09-29

Report date

2022-10-12

Termination date

2023-07-25

Voluntary/Mandated

Voluntary: Firm initiated

Location

Warren, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1550-2022