Drug 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
D-0341-2018
Product summary
- Event
- Event 79023
- Status
- Terminated
- Classification
- Class II
- Quantity
- 7174 bottles
- Official record key
drug-enforcement:D-0341-2018
Official wording
Reason: CGMP deviations.
Code information: 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
Distribution pattern: Nationwide
Derived failure modes
-
Manufacturing or process control
CGMP deviations