Class III
Ongoing
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.
This recall is currently active, issued August 27, 2025. It was issued by Cipla Usa, Inc..
- Company
- Cipla Usa, Inc.
- Recall Initiated
- July 24, 2025
- Posted
- August 27, 2025
- Recall Number
- D-0593-2025
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 20352 packs (1x 200 MD)
- Firm Location
- Warren, NJ, United States
- Official Source
- View on FDA website ↗
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.
Distribution
U.S. Nationwide.
Lot / Code Info
Lot#: 4IB0519, Exp. 04/30/2026
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