FDA-Drug2021-09-29Class II
Arformoterol Tartrate Inhalation Solution 15 mcg*/2 mL For Oral Inhalation Only Rx Only Manufactured by: Glenmark Pharmaceuticals Inc., USA Monroe, NC 28110 Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430 a) 60x2 mL Sterile Unit-Dose Vials NDC 68462-833-65; b) 30x2 mL Sterile Unit-Dose Vials NDC 68462-833-35
Glenmark Pharmaceuticals Inc., USA
Hazard
Lack of Assurance of Sterility
Sold states
Nationwide.
Affected count
a) 5362 inhalers; b) 5593 inhalers
Manufactured in
750 Corporate Dr, Mahwah, NJ, United States
Products
Arformoterol Tartrate Inhalation Solution 15 mcg*/2 mL For Oral Inhalation Only Rx Only Manufactured by: Glenmark Pharmaceuticals Inc., USA Monroe, NC 28110 Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430 a) 60x2 mL Sterile Unit-Dose Vials NDC 68462-833-65; b) 30x2 mL Sterile Unit-Dose Vials NDC 68462-833-35
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0827-2021Don't want to check this manually?
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