Drug 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.
D-0593-2025
Product summary
- Firm
- Cipla USA, Inc.
- Event
- Event 97304
- Status
- Ongoing
- Classification
- Class III
- Quantity
- 20352 packs (1x 200 MD)
- Official record key
drug-enforcement:D-0593-2025
Official wording
Reason: 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.
Code information: Lot#: 4IB0519, Exp. 04/30/2026
Distribution pattern: U.S. Nationwide.
Derived failure modes
-
Potency or specification failure
Out of specification