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.
Reported: August 27, 2025 Initiated: July 24, 2025 #D-0593-2025
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.
Details
- Recalling Firm
- Cipla USA, Inc.
- Units Affected
- 20352 packs (1x 200 MD)
- Distribution
- U.S. Nationwide.
- Location
- Warren, NJ
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Cipla USA, Inc.. Units affected: 20352 packs (1x 200 MD).
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on August 27, 2025. Severity: Low. Recall number: D-0593-2025.
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