Drug recall D-0341-2021

Class II Terminated reported May 5, 2021

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

Reason for recall

CGMP deviation: Product found to contain trace amounts of NMBA

Lots and codes

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

Recall details

Recalling firm
PD-Rx Pharmaceuticals, Inc., Oklahoma City, OK
Quantity
576 bottles
Distribution
AK, AZ, CA, CO, FL, KY, MA, MI, MN, NC, OH, OR, WI, WY
Type
Voluntary: Firm initiated
Recall initiated
March 8, 2019
Terminated
June 16, 2021

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