Product: Levalbuterol Inhalation Solution, USP, 0.31 mg/ 3 mL, 3 mL Vials, Rx Only. Manufactured by: Cipla Ltd. Plot 9 & 10, Indure, SEZ, Pithampur, M.P.-454 775, INDIA, Manufactured for: Dr. Reddy's Laboratories, Inc., Princeton NJ 08640.  NDC: 43598-412-25.
Reason for recall: Failed Impurities/Degradation Specifications: Product is out of specification for a known degradant.
Recall initiated: 20150424
Status: Terminated
Classification: Class III
Recall type: Voluntary: Firm initiated