FDA Recall D-0938-2023
Cipla USA, Inc. · Warren, NJ
Class I — life-threatening Terminated 618 days on record
Highest impact — Class I recall — FDA determination of strong likelihood of serious adverse health consequence 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
Reason for recall
Defective container: empty inhaler and leakage observed through the inhaler valve due to partially missing bottom seat (gasket).
Recall record
- Recall number
D-0938-2023- Classification
- Class I
- Status
- Terminated
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- Letter
- Distribution
- Nationwide in the US
- Recall initiated
- 2023-06-27
- Classified by FDA Center
- 2023-07-21
- FDA published
- 2023-07-19
- Terminated
- 2025-03-06
- Recalling firm
- Cipla USA, Inc.
- Firm location
- Warren, NJ
Drug identification
- Brand name(s)
- ALBUTEROL SULFATE
- Generic name(s)
- ALBUTEROL SULFATE
- Manufacturer(s)
- Cipla USA Inc.
- NDC(s)
69097-142- Route(s)
- RESPIRATORY (INHALATION)