Cipla USA, Inc.: Drug Recall

Recall #D-0938-2023 · 06/27/2023

Class I: Dangerous

Recall Details

Recall Number
D-0938-2023
Classification
Class I
Product Type
Drug
Recalling Firm
Cipla USA, Inc.
Status
Terminated
Date Initiated
06/27/2023
Location
Warren, NJ, United States
Voluntary/Mandated
Voluntary: Firm initiated
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).

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

Distribution Pattern

Nationwide in the US

Other Recalls by Cipla USA, Inc.

View all recalls by Cipla USA, Inc. →

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.