FDA recall D-1545-2022

Product

Budesonide Inhalation Suspension 0.25mg/2mL, For Inhalation Only, Rx Only, 1 envelope x five 2 mL Single Dose Ampules per pouch, Sterile Suspension, Manufactured by: Cipla Ltd., India, Manufactured for Cipla USA Inc., Warren NJ, NDC# 69097-318-86.

Reason for recall

Lack of Assurance of Sterility

Distribution

Nationwide in the USA and Puerto Rico

Key facts

Status

Terminated

Initiation date

2022-09-15

Report date

2022-10-05

Termination date

2024-01-10

Voluntary/Mandated

Voluntary: Firm initiated

Location

Warren, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1545-2022