Drug Enforcement D-0593-2025

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.

Status

Ongoing

Classification

Class III

Report Date

August 27, 2025

Termination Date

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Product Information

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.
Product quantity
20352 packs (1x 200 MD)
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.
Recall initiation reason
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Initial firm notification
Letter
Distribution pattern
U.S. Nationwide.

Location & Firm

Recalling firm
Cipla USA, Inc.
Address
10 Independence Blvd, N/A

United States
Voluntary / Mandated
Voluntary: Firm initiated
Status date
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Codes & Dates

Recall number
D-0593-2025
Event ID
97304
Recall initiation date
July 24, 2025
Center classification date
August 20, 2025
Code info
Lot#: 4IB0519, Exp. 04/30/2026
More code info
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