Recall: D-1545-2022

Class II - Potentially Harmful

Class IIClassification

2022-09-15Initiated

TerminatedStatus

CIPLAFirm

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

Lack of Assurance of Sterility

Distribution

Nationwide in the USA and Puerto Rico

Source: FDA drug enforcement report via openFDA (Voluntary: Firm initiated). If you take this product, talk to your pharmacist or doctor before stopping it.