PlainRecalls
FDA Drug Low Class III Terminated

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

Reported: February 1, 2017 Initiated: January 12, 2017 #D-0439-2017

Product Description

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.

Details

Recalling Firm
Actavis Inc
Units Affected
164,844 units
Distribution
Nationwide in the US
Location
Parsippany, NJ

Frequently Asked Questions

What product 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. Recalled by Actavis Inc. Units affected: 164,844 units.
Why was this product recalled?
Failed Impurities/Degradation Specifications: Product is out of specification for a known degradant.
Which agency issued this recall?
This recall was issued by the FDA Drug on February 1, 2017. Severity: Low. Recall number: D-0439-2017.