December 2019 FDA Recall Raloxifene Hydrochloride by American Health Packaging
D-0854-2020 - Failed Dissolution Specifications

This Class II drug recall was voluntarily initiated by American Health Packaging on December 4, 2019 for the product Raloxifene Hydrochloride. The FDA reported the reason for recall as failed dissolution specifications. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-0854-2020

Reason for Recall
Failed Dissolution Specifications: Low out of specification results obtained during stability testing.
Initiated
12-04-2019
Reported
02-19-2020
Quantity
973 cartons

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
84898
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
American Health Packaging
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide within the United States
Termination Date About Termination Date
Date that FDA officially terminated the recall.
08-04-2022
Product Description About Product Description
Full technical description of the 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

Batch or Lot Expiration Information

Lot# :180276A, Exp date 02/29/2020

Affected Packages Involved in this Recall

60687-266-11 Raloxifene Hydrochloride
60687-266-21 Raloxifene Hydrochloride