Drug recall D-0574-2016
Product
Phentermine Hydrochloride Capsules, USP, 15 mg, packaged in a) 7-count (NDC 55289-791-07), b) 14-count (NDC 55289-791-14), c) 28-count (NDC 55289-791-28), d) 30-count (NDC 55289-791-30), and e) 60-count (NDC 55289-791-60) bottles, Packaged by PD-RX Pharmaceuticals, INC Oklahoma City, OK 73127, MFG: KVK-TECH, INC Newtown, PA 18840.
Reason for recall
Failed impurities/Degradation specifications: out of specification results for individual unknown and total impurity at the 12th month room temperature stability test station
Lots and codes
Lot #: a) H14C80, Exp 08/16; I14G36, Exp 09/16; b) H14A86, Exp 07/16; c) H14C83, Exp 08/16, K14A21, Exp 11/16; d) H14F25, Exp 08/16; e) L14C42, Exp 12/16.
Recall details
- Recalling firm
- PD-Rx Pharmaceuticals, Inc., Oklahoma City, OK
- Quantity
- 1685 bottles
- Distribution
- Nationwide
- Type
- Voluntary: Firm initiated
- Recall initiated
- July 21, 2015
- Terminated
- December 23, 2016
Related products
- Phentermine Hydrochloride – drug information
- NDC 55289-791 Phentermine Hydrochloride · Phentermine Hydrochloride 15 mg/1 · PD-Rx Pharmaceuticals, Inc.