Cipla Limited recalls Levalbuterol Inhalation Solution, USP, 0.31 mg/ 3 mL, 3 mL Vials, Rx Only. Manufactured by: Cipla Ltd. Plot 9 & 10, Indu
Recalled May 20, 2015 · FDA recall D-1078-2015 · Cipla
Hazard
Failed Impurities/Degradation Specifications: Product is out of specification for a known degradant. · FDA Class III
Units
140,625 Vials
Sold at
U.S. Nationwide including Puerto Rico.
Description
Failed Impurities/Degradation Specifications: Product is out of specification for a known degradant.
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.
Manufacturer(s)
Cipla Limited
Made in
India
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →