Glenmark Pharmaceuticals Inc., USA recalls Arformoterol Tartrate Inhalation Solution 15 mcg*/2 mL For Oral Inhalation Only Rx Only Manufactured by: Glenmark Pharma
Recalled September 29, 2021 · FDA recall D-0827-2021 · Glenmark Pharmaceuticals Inc., USA
Hazard
Lack of Assurance of Sterility · FDA Class II
Units
a) 5362 inhalers; b) 5593 inhalers
Sold at
Nationwide.
Description
Lack of Assurance of Sterility
Product
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
Manufacturer(s)
Glenmark Pharmaceuticals Inc., USA
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →