D-0341-2018 Class II Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- February 7, 2018
- Initiation Date
- January 25, 2018
- Termination Date
- May 7, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 7174 bottles
Product Description
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.
Distribution Pattern
Nationwide
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