RecallDepth
Class II Terminated

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.

Company
Cipla
Recall Initiated
September 15, 2022
Posted
October 5, 2022
Recall Number
D-1545-2022
Voluntary / Mandated
Voluntary: Firm initiated
Quantity
641,160 ampules
Firm Location
Warren, NJ, United States

Reason for Recall

Lack of Assurance of Sterility

Distribution

Nationwide in the USA and Puerto Rico

Lot / Code Info

Lot #s: GA20080, GA20081, GA20094, Exp. 01/2024

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