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Roxane Laboratories Recalls
2 recalls on record · February 1, 2017 to February 1, 2017 · Drugs
February 1, 2017DrugsFDA
Roxane Laboratories, Inc. recalls Azelastine Hydrochloride Nasal Solution (Nasal Spray), 0.1% (137 mcg per spray), packaged in 30 mL bottles, Rx only, Dis
Hazard: Defective Delivery System: out of specification result for droplet size distribution at the d90 measurement testing during the 6 month time point..
February 1, 2017DrugsFDA
Roxane Laboratories, Inc. recalls Furosemide Tablets USP, 20 mg, 1000 count bottles, Rx only, Roxane Laboratories, Inc., Columbus, Ohio 43216, NDC 0054-4
Hazard: Failed Tablet/Capsule Specifications: An unusually thick tablet was reported through a complaint.