FDA-Drug2017-02-01Class III

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

Actavis Inc
Hazard

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

Sold states
Nationwide in the US
Affected count
164,844 units
Manufactured in
400 Interpace Pkwy, N/A, Parsippany, NJ, United States
Products
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

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0439-2017

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