Class III
Terminated
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.
- Company
- Pd-Rx Pharmaceuticals, Inc.
- Recall Initiated
- July 21, 2015
- Posted
- January 27, 2016
- Recall Number
- D-0574-2016
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 1685 bottles
- Firm Location
- Oklahoma City, OK, United States
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
Distribution
Nationwide
Lot / Code Info
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.
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