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:
Check against the official notice below — it lists the full affected range.
PD-Rx Pharmaceuticals, Inc. is recalling Phentermine Hydrochloride Capsules, USP, 15 mg, distributed nationwide in bottles containing 7, 14, 28, or 30 capsules. The recall affects 1,685 bottles across multiple lot numbers with expiration dates ranging from July 2016 to December 2016. The capsules are being recalled because they failed impurity and degradation specifications during 12-month room temperature stability testing, with results showing out-of-specification levels for individual unknown impurities and total impurities.
The recall record does not specify a remedy or recommended action for affected consumers.
Written by software from the official notice below. Not reviewed by a lawyer.
Failed impurities/Degradation specifications: out of specification results for individual unknown and total impurity at the 12th month room temperature stability test station
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 Quantity: 1685 bottles 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.
Official record: FDA (Drug enforcement) ↗
Republished from the official source above; details can change — the source record controls.