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Recall Observatory FDA recall evidence

Drug product

Losartan Potassium USP, 50 mg, RX Only, Pkg By PD-Rx Pharmaceuticals Incorporated Oklahoma City, OK 73127 a) 60 Tablets NDC: 43063-854-60; b) 90 Tablets NDC: 43063-0854-90

D-0341-2021

March 08, 2019

Class II

Product summary

Firm
PD-Rx Pharmaceuticals, Inc.
Event
Event 87774
Status
Terminated
Classification
Class II
Quantity
576 bottles
Official record key
drug-enforcement:D-0341-2021

Official wording

Reason: CGMP deviation: Product found to contain trace amounts of NMBA

Code information: Lots: A19B99 Exp. 11/30/2019; B19A26 Exp. 11/30/2019; B19A69 Exp. 11/30/2019; E18F12 Exp.: 09/30/19; F18A12 Exp.: 09/30/19; F18F06 Exp.: 09/30/19; G18B43 Exp.: 09/30/19; G18C43 Exp.: 09/30/19; G18F75 Exp.: 09/30/19; H18D55 Exp.: 09/30/19; I18A11 Exp.: 09/30/19; I18E32 Exp.: 09/30/19; J18A90 Exp.: 09/30/19; J18D50 Exp. 11/30/2019; L18D01 Exp. 11/30/2019

Distribution pattern: AK, AZ, CA, CO, FL, KY, MA, MI, MN, NC, OH, OR, WI, WY

Derived failure modes

  • Manufacturing or process control

    reason.manufacturing_process_control · v1.0.0

    CGMP deviation