Recall: D-0938-2023

Class I - Dangerous

Class IClassification

2023-06-27Initiated

TerminatedStatus

Cipla USA, Inc.Firm

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

Defective container: empty inhaler and leakage observed through the inhaler valve due to partially missing bottom seat (gasket).

Distribution

Nationwide in the US

Source: FDA drug enforcement report via openFDA (Voluntary: Firm initiated). If you take this product, talk to your pharmacist or doctor before stopping it.