FDA-Drug2015-05-20Class III
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.
Cipla Limited
Hazard
Failed Impurities/Degradation Specifications: Product is out of specification for a known degradant.
Sold states
U.S. Nationwide including Puerto Rico.
Affected count
140,625 Vials
Manufactured in
Plot No. 9 & 10 Pharma Zone Phase II, Section III Indore Special Economic Zone, Pithampur, District Dhar, N/A, India
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1078-2015Don't want to check this manually?
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