Drug Enforcement D-0938-2023

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

Status

Terminated

Classification

Class I

Report Date

July 19, 2023

Termination Date

March 6, 2025

Product Information

Product description
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
Product quantity
278,538 canisters
Reason for recall
Defective container: empty inhaler and leakage observed through the inhaler valve due to partially missing bottom seat (gasket).
Recall initiation reason
—
Initial firm notification
Letter
Distribution pattern
Nationwide in the US

Location & Firm

Recalling firm
Cipla USA, Inc.
Address
10 Independence Blvd, N/A

United States
Voluntary / Mandated
Voluntary: Firm initiated
Status date
—

Codes & Dates

Recall number
D-0938-2023
Event ID
92616
Recall initiation date
June 27, 2023
Center classification date
July 21, 2023
Code info
Lot # IB20045, IB20055, IB20056, IB20057, IB20059, IB20072, Exp Nov. 30, 2023
More code info
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