Recall: D-0854-2020

Class II - Potentially Harmful

Class IIClassification

2019-12-04Initiated

TerminatedStatus

American Health PackagingFirm

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

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

Distribution

Nationwide within the United States

Source: FDA drug enforcement report via openFDA (Voluntary: Firm initiated). If you take this product, talk to your pharmacist or doctor before stopping it.