Roxane Laboratories, Inc. Recalls
FDA
Showing 1-2 of 2 recalls
Furosemide Tablets USP, 20 mg, 1000 count bottles, Rx only, Roxane Laboratories, Inc., Columbus, Ohio 43216, NDC 0054-4297-31.
Failed Tablet/Capsule Specifications: An unusually thick tablet was reported through a complaint.
Azelastine Hydrochloride Nasal Solution (Nasal Spray), 0.1% (137 mcg per spray), packaged in 30 mL bottles, Rx only, Distributed by: West-Ward Pharmaceuticals Corp., Eatontown, NJ 07724, NDC 0054-0293-99
Defective Delivery System: out of specification result for droplet size distribution at the d90 measurement testing during the 6 month time point..