D-0938-2023 Class I Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- July 19, 2023
- Initiation Date
- June 27, 2023
- Termination Date
- March 6, 2025
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 278,538 canisters
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
Reason for Recall
Defective container: empty inhaler and leakage observed through the inhaler valve due to partially missing bottom seat (gasket).
Distribution Pattern
Nationwide in the US
Code Information
Lot # IB20045, IB20055, IB20056, IB20057, IB20059, IB20072, Exp Nov. 30, 2023