Albuterol Sulfate, Inhalation Aerosol, 90 mcg, 200 metered Inhalations, NET CONTENT 6.7 g, Manufa...
FDA Recall #D-0593-2025 — Class III — July 24, 2025
Product Description
Albuterol Sulfate, Inhalation Aerosol, 90 mcg, 200 metered Inhalations, NET CONTENT 6.7 g, Manufactured by: Cipla Ltd, Indore, SEZ, Pithampur, India; Manufactured for: Cipla USA, Inc. 10 Independence Boulevard, Suite 300, Warren, NJ 07059, NDC 69097-142-60.
Reason for Recall
Failed Stability Specifications: Out of specification results was observed in Induction Port during the analysis of Particle size distribution at the 12-month time point.
Recalling Firm
Cipla USA, Inc. — Warren, NJ
Classification
Class III — Not likely to cause adverse health consequences.
Product Type
Drugs
Product Quantity
20352 packs (1x 200 MD)
Distribution
U.S. Nationwide.
Code Information
Lot#: 4IB0519, Exp. 04/30/2026
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated