Drug product
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
D-0938-2023
Product summary
- Firm
- Cipla USA, Inc.
- Event
- Event 92616
- Status
- Terminated
- Classification
- Class I
- Quantity
- 278,538 canisters
- Official record key
drug-enforcement:D-0938-2023
Official wording
Reason: Defective container: empty inhaler and leakage observed through the inhaler valve due to partially missing bottom seat (gasket).
Code information: Lot # IB20045, IB20055, IB20056, IB20057, IB20059, IB20072, Exp Nov. 30, 2023
Distribution pattern: Nationwide in the US
Derived failure modes
-
Unknown
Defective container: empty inhaler and leakage observed through the inhaler valve due to partially missing bottom seat (gasket).