Home / Recalls / PD-Rx Pharmaceuticals, Inc. / D-1118-2017

D-1118-2017 Class III Terminated

Recalled by PD-Rx Pharmaceuticals, Inc. — Oklahoma City, OK

Recall Details

Product Type
Drugs
Report Date
August 30, 2017
Initiation Date
August 11, 2017
Termination Date
January 29, 2020
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
3440 bottles

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

Reason for Recall

Failed Impurities/Degradation Specifications:Out of specification results for individual unknown impurities at 30th month Room Temperature Retained Sample stabilities test .

Distribution Pattern

Nationwide.

Code Information

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.

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  • D-0557-2023 Class II — Montelukast Sodium USP, 10 mg, 30 count-bottles, Rx only, Intas Pharm, Limited A (April 6, 2023)
  • D-1161-2022 Class II — Losartan Potassium Tablets, USP 25 mg, 90 Tablets bottles, Rx Only Marketed and (June 6, 2022)
  • D-1162-2022 Class II — Losartan Potassium Tablets, USP 50 mg, 90 Tablets bottles, Rx Only Marketed and (June 6, 2022)
  • D-1163-2022 Class II — Losartan Potassium Tablets, USP 100 mg, 90 Tablets bottles, Rx Only, Marketed an (June 6, 2022)
  • D-0060-2021 Class II — metformin HCL ER 750 mg Rx only Pkg By: PD-Rx Pharmaceuticals Incorporated Oklah (October 6, 2020)