Recalls / Class I
Class ID-0938-2023
Class I— FDA's most serious classification, issued when there is a reasonable probability that use of or exposure to the drug will cause serious adverse health consequences or death.
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
- Brand name
- Albuterol Sulfate
- Generic name
- Albuterol Sulfate
- Active ingredient
- Albuterol Sulfate
- Route
- Respiratory (inhalation)
- NDC
- 69097-142
- FDA application
- ANDA209959
- Affected lot / code info
- Lot # IB20045, IB20055, IB20056, IB20057, IB20059, IB20072, Exp Nov. 30, 2023
Why it was recalled
Defective container: empty inhaler and leakage observed through the inhaler valve due to partially missing bottom seat (gasket).
Recalling firm
- Firm
- Cipla USA, Inc.
- Manufacturer
- Cipla USA Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 10 Independence Blvd, N/A, Warren, New Jersey 07059-2730
Distribution
- Quantity
- 278,538 canisters
- Distribution pattern
- Nationwide in the US
Timeline
- Recall initiated
- 2023-06-27
- FDA classified
- 2023-07-21
- Posted by FDA
- 2023-07-19
- Terminated
- 2025-03-06
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0938-2023. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.