RecallDepth
Class I Terminated

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

Company
Cipla Usa, Inc.
Recall Initiated
June 27, 2023
Posted
July 19, 2023
Recall Number
D-0938-2023
Voluntary / Mandated
Voluntary: Firm initiated
Quantity
278,538 canisters
Firm Location
Warren, NJ, United States

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

Lot / Code Info

Lot # IB20045, IB20055, IB20056, IB20057, IB20059, IB20072, Exp Nov. 30, 2023

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