Class III
Terminated
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.
- Company
- Cipla Limited
- Recall Initiated
- April 24, 2015
- Posted
- May 20, 2015
- Recall Number
- D-1078-2015
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 140,625 Vials
- Firm Location
- Pithampur, District Dhar, India
Reason for Recall
Failed Impurities/Degradation Specifications: Product is out of specification for a known degradant.
Distribution
U.S. Nationwide including Puerto Rico.
Lot / Code Info
Lot #: FA4022; Expiry: December 2015.
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