July 2015 FDA Recall Drug by Pd-rx Pharmaceuticals, Inc.
D-0559-2016 - cGMP Deviations

This Class II drug recall was voluntarily initiated by Pd-rx Pharmaceuticals, Inc. on July 10, 2015 for the product Drug. The FDA reported the reason for recall as cgmp deviations. The product was distributed in Alabama and the recall is currently terminated.

Recall Number: D-0559-2016

Reason for Recall
cGMP Deviations
Initiated
07-10-2015
Reported
01-06-2016
Quantity
9 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
72942
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.
PD-Rx Pharmaceuticals, Inc.
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.
E-Mail
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Alabama
Termination Date About Termination Date
Date that FDA officially terminated the recall.
03-08-2017
Product Description About Product Description
Full technical description of the product.
Clonidine Hydrochloride Tablets, USP, 0.1 mg, 100-count bottles, Rx only, Packaged by PD-RX Pharmaceuticals, Inc., Oklahoma City, OK 73127, MFG: Mutual Pharm. Co. Inc., Philadelphia, PA 19124, NDC 43063-509-01

Batch or Lot Expiration Information

Lot# B14D26, Exp 02/16