Raloxifene Hydrochloride Tablet
FDA Recall NDC 60687-266
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 1 recorded enforcement report(s) associated with Raloxifene Hydrochloride (NDC 60687-266). A significant event, classified as Class II, was initiated on Dec 04, 2019 by American Health Packaging. The reported reason for this action was: "Failed Dissolution Specifications: Low out of specification results obtained during stability testing."
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
Reported Recall Events
Class II Terminated
Failed Dissolution Specifications: Low out of specification results obtained during stability testing.
Dec 04, 2019
Feb 19, 2020
973 cartons
Recall Profile & Regulatory Data
Event ID
84898
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
American Health Packaging
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide within the United States
Termination Date
Aug 04, 2022
Product Description
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
Batch or Lot Expiration Information
Lot# :180276A, Exp date 02/29/2020
Affected Packages Involved in this Recall
60687-266-11Product
60687-266-21Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
