Phentermine Hydrochloride Capsule
FDA Recall NDC 55289-791
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 2 recorded enforcement report(s) associated with Phentermine Hydrochloride (NDC 55289-791). A significant event, classified as Class III, was initiated on Aug 11, 2017 by Pd-rx Pharmaceuticals, Inc.. The reported reason for this action was: "Failed Impurities/Degradation Specifications:Out of specification results for individual unknown impurities at 30th month Room Temperature Retained Sample stabilities test ."
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
Reported Recall Events
August 2017 Class III Recall: Failed Impurities/Degradation Specifications
Recall Number
Class III Terminated
Failed Impurities/Degradation Specifications:Out of specification results for individual unknown impurities at 30th month Room Temperature Retained Sample stabilities test .
Aug 11, 2017
Aug 30, 2017
3440 bottles
Recall Profile & Regulatory Data
Event ID
77915
Classification
Class III
Enforcement Status
Terminated
Recalling Firm
PD-Rx Pharmaceuticals, Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide.
Termination Date
Jan 29, 2020
Product Description
Phentermine Capsules, 15 mg, a) 7-count bottle (NDC 55289-791-07), b) 14-count bottle ( NDC 55289-791-14), c) 21-count bottle (NDC 55289-791-21), d) 30-count bottle (NDC 55289-791-30), e) 60-count bottle (NDC 55289-791-60), Packaged by PD-Rx Pharmaceuticals, Incorporated, Oklahoma City, OK. 73127 Mfg: KVK-Tech, Inc. Newtown, PA 18940
Batch or Lot Expiration Information
Lot# Lots: a) H15E22, Exp. 8/31/17; J15E02, Exp. 10/31/17. b) J15A53, Exp. 10/31/17; D16C78, Exp.12/31/17; c)J15D54, Exp. 10/31/17; d)H15B60, Exp. 8/31/17; e) J15A49, Exp. 10/31/17; C16A14, Exp. 12/31/17.
Affected Packages Involved in this Recall
55289-791-07Product
55289-791-14Product
55289-791-15Product
55289-791-21Product
55289-791-28Product
55289-791-30Product
55289-791-60Product
Class III Terminated
Failed impurities/Degradation specifications: out of specification results for individual unknown and total impurity at the 12th month room temperature stability test station
Jul 21, 2015
Jan 27, 2016
1685 bottles
Recall Profile & Regulatory Data
Event ID
72941
Classification
Class III
Enforcement Status
Terminated
Recalling Firm
PD-Rx Pharmaceuticals, Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide
Termination Date
Dec 23, 2016
Product Description
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.
Batch or Lot Expiration Information
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.
Affected Packages Involved in this Recall
55289-791-07Product
55289-791-14Product
55289-791-15Product
55289-791-21Product
55289-791-28Product
55289-791-30Product
55289-791-60Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
