FDA recall D-0938-2023

Product

Albuterol Sulfate Inhalation Aerosol, 90 mcg, 200 Metered Inhalation, net content 6.7 g canister packaged in a box, Rx only, Manufactured by: Cipla Ltd, Indore SE Z, Pithampur, India, Manufactured for: Cipla USA, Inc., 10 Independence Boulevard, Suite 300, Warren, NJ, 07059, NDC 69097-142-60

Reason for recall

Defective container: empty inhaler and leakage observed through the inhaler valve due to partially missing bottom seat (gasket).

Distribution

Nationwide in the US

Key facts

Status

Terminated

Initiation date

2023-06-27

Report date

2023-07-19

Termination date

2025-03-06

Voluntary/Mandated

Voluntary: Firm initiated

Location

Warren, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0938-2023