Roxane Laboratories recalls
FDA enforcement reports naming Roxane Laboratories, Inc. as the recalling firm.
- Recall reports
- 2
- Class I (serious)
- 0
- Most recent report
- Feb 1, 2017
- Feb 1, 2017Azelastine Hydrochloride Nasal Solution (Nasal Spray), 0Drug · Roxane Laboratories, Inc.Defective Delivery System: out of specification result for droplet size distribution at the d90 measurement testing during the 6 month time point..Class III
- Feb 1, 2017Furosemide Tablets USP, 20 mg, 1000 count bottles, Rx only, Roxane Laboratories, IncDrug · Roxane Laboratories, Inc.Failed Tablet/Capsule Specifications: An unusually thick tablet was reported through a complaint.Class II