FDA-Drug2017-08-09Class III
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.
Teva Pharmaceuticals USA
Hazard
Failed Impurities/Degradation Specifications: high out of specification results for related compound D.
Sold states
Nationwide in the USA and Puerto Rico
Affected count
401,750 cartons
Manufactured in
1090 Horsham Rd, N/A, North Wales, PA, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1039-2017Don't want to check this manually?
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