FDA recall D-0854-2020

Product

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

Reason for recall

Failed Dissolution Specifications: Low out of specification results obtained during stability testing.

Distribution

Nationwide within the United States

Key facts

Status

Terminated

Initiation date

2019-12-04

Report date

2020-02-19

Termination date

2022-08-04

Voluntary/Mandated

Voluntary: Firm initiated

Location

Columbus, OH, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0854-2020