Actavis Inc recalls Albuterol Sulfate Inhalation Solution, USP, 0.021% (0.63 mg / 3 mL), 3mL Vials, Rx only, Mfd. for Watson Laboratories I…

Recall date

January 12, 2017

Source

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

Recall number

D-0439-2017

FDA classification

Class III

Brand / firm

Actavis Inc

Sold / distributed

Nationwide in the US

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

Albuterol Sulfate Inhalation Solution, USP, 0.021% (0.63 mg / 3 mL), 3mL Vials, Rx only, Mfd. for Watson Laboratories Inc., Corona, CA 92880 USA, Mfd. by Cipla Ltd. Verna, Goa India, NDC 0591-3467-53