D-0593-2025 Class III Ongoing
FDA drug recall D-0593-2025 was initiated by Cipla USA, Inc. on Jul 24, 2025 and is designated Class III. 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. The recall status is ongoing. Affected quantity: 20352 packs (1x 200 MD).
Recall Details
- Product Type
- Drugs
- Report Date
- Aug 27, 2025
- Initiation Date
- Jul 24, 2025
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 20352 packs (1x 200 MD)
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.
Distribution Pattern
U.S. Nationwide.
Code Information
Lot#: 4IB0519, Exp. 04/30/2026
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0593-2025
- openFDA file date
- Nov 3, 2026
- Loaded by RegDataLab
- Nov 4, 2026