FDA-Drug2020-02-19Class II
Raloxifene Hydrochloride Tablets, USP, 60 mg, 30 Tablets (3 x 10 blister cards), Rx Only, Packaged and Distributed by: American Health Packaging, Columbus, Ohio 43217. NDC carton: 60687-266-21; NDC Unit Dose: 60687-266-11
American Health Packaging
Hazard
Failed Dissolution Specifications: Low out of specification results obtained during stability testing.
Sold states
Nationwide within the United States
Affected count
973 cartons
Manufactured in
2550 John Glenn Ave Ste A, Columbus, OH, United States
Products
Raloxifene Hydrochloride Tablets, USP, 60 mg, 30 Tablets (3 x 10 blister cards), Rx Only, Packaged and Distributed by: American Health Packaging, Columbus, Ohio 43217. NDC carton: 60687-266-21; NDC Unit Dose: 60687-266-11
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0854-2020Don't want to check this manually?
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