D-1078-2015 Class III Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- May 20, 2015
- Initiation Date
- April 24, 2015
- Termination Date
- February 14, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 140,625 Vials
Product Description
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.
Distribution Pattern
U.S. Nationwide including Puerto Rico.
Code Information
Lot #: FA4022; Expiry: December 2015.