FDAHealthJuly 24, 2025
Cipla USA, Inc. — 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
⚠️ 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.
Is this relevant to me?
- Geography
- Nationwide
- Source agency
- FDA
- Category
- Health
- Published
- July 24, 2025
U.S. Nationwide.
What's affected?
- Product
- 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.
- Brand
- ALBUTEROL SULFATE
- Lot code
- 4IB0519
Additional details
Lot#: 4IB0519, Exp. 04/30/2026
What should I do?
Recommended action
Class III recall. Voluntary: Firm initiated Quantity affected: 20352 packs (1x 200 MD).
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