Cipla Limited recalls Levalbuterol Inhalation Solution, USP, 0.31 mg/ 3 mL, 3 mL Vials, Rx Only. Manufactured by: Cipla Ltd. Plot 9 & 10, Ind…

Recall date

April 24, 2015

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

D-1078-2015

FDA classification

Class III

Brand / firm

Cipla Limited

Sold / distributed

U.S. Nationwide including Puerto Rico.

Why it was recalled

Failed Impurities/Degradation Specifications: Product is out of specification for a known degradant.

Class III means the product violates regulations but is not likely to cause harm.

What was recalled

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.