Teva Pharmaceuticals USA recalls Albuterol Sulfate Inhalation Solution, 0.021% (0.63 mg/3mL), packaged in 5 pouches of 5 x 3mL Sterile Unit-Dose Vials F…

Recall date

July 25, 2017

Source

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

Recall number

D-1039-2017

FDA classification

Class III

Brand / firm

Teva Pharmaceuticals USA

Sold / distributed

Nationwide in the USA and Puerto Rico

Why it was recalled

Failed Impurities/Degradation Specifications: high out of specification results for related compound D.

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

What was recalled

Albuterol Sulfate Inhalation Solution, 0.021% (0.63 mg/3mL), packaged in 5 pouches of 5 x 3mL Sterile Unit-Dose Vials For Inhalation per carton, Rx only, Mfd. for: Watson Laboratories, Inc., Corona, CA 92880; Mfd. by: Cipla Ltd., Verna, Goa INDIA, NDC 0591-3467-53.