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 Fo
Recalled August 9, 2017 · FDA recall D-1039-2017 · Teva Pharmaceuticals USA
Hazard
Failed Impurities/Degradation Specifications: high out of specification results for related compound D. · FDA Class III
Units
401,750 cartons
Sold at
Nationwide in the USA and Puerto Rico
Description
Failed Impurities/Degradation Specifications: high out of specification results for related compound D.
Product
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.
Manufacturer(s)
Teva Pharmaceuticals USA
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →