January 2018 FDA Recall Drug by Pd-rx Pharmaceuticals, Inc.
D-0341-2018 - CGMP deviations.

This Class II drug recall was voluntarily initiated by Pd-rx Pharmaceuticals, Inc. on January 25, 2018 for the product Drug. The FDA reported the reason for recall as cgmp deviations.. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-0341-2018

Reason for Recall
CGMP deviations.
Initiated
01-25-2018
Reported
02-07-2018
Quantity
7174 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
79023
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.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
05-07-2020
Product Description About Product Description
Full technical description of the product.
PD-Rx Pharmaceuticals Incorporated Ibuprofen 200 mg tablets a) 24 tablets NDC 55289-673-24; b) 30 tablets NDC 55289-673-30; c) 50 tablets NDC 55289-673-50; d) 60 tablets NDC 55289-673-60

Batch or Lot Expiration Information

Lot# Lots: K16E92 Exp. 5/31/18; B17A87 Exp. 5/31/18; E17A51 Exp. 5/31/18; L16B59 Exp. 1/31/18; K16E01 Exp. 5/31/18; A17F21 Exp. 5/31/18; B17D71 Exp. 5/31/18; D17E92 Exp. 5/31/18; J16D13 Exp. 1/31/18; A17D63 Exp. 5/31/18; E17A18 Exp. 5/31/18; F17B87 Exp. 5/31/18; C17C58 Exp. 5/31/18