FDA recall D-0439-2017

Product

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

Reason for recall

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

Distribution

Nationwide in the US

Key facts

Status

Terminated

Initiation date

2017-01-12

Report date

2017-02-01

Termination date

2018-03-05

Voluntary/Mandated

Voluntary: Firm initiated

Location

Parsippany, NJ, United States

Primary source

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