Drug recall D-0341-2018

Class II Terminated reported Feb 7, 2018

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

Reason for recall

CGMP deviations.

Lots and codes

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

Recall details

Recalling firm
PD-Rx Pharmaceuticals, Inc., Oklahoma City, OK
Quantity
7174 bottles
Distribution
Nationwide
Type
Voluntary: Firm initiated
Recall initiated
January 25, 2018
Terminated
May 7, 2020