PD-Rx Pharmaceuticals, Inc.: 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

Is my product affected?

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

• Brand LOSARTAN POTASSIUM

Check against the official notice below — it lists the full affected range.

What happened

PD-Rx Pharmaceuticals, Inc. is recalling Losartan Potassium USP 50 mg tablets packaged in bottles of 60 or 90 tablets due to a manufacturing deviation. The product was found to contain trace amounts of NMBA, a substance that should not be present. The affected lots are A19B99, B19A26, B19A69, E18F12, F18A12, F18F06, G18B43, G18C43, G18F75, H18D55, I18A11, I18E32, J18A90, J18D50, and L18D01, with various expiration dates between September 30, 2019 and November 30, 2019. A total of 576 bottles were distributed across Alaska, Arizona, California, Colorado, Florida, Kentucky, Massachusetts, Michigan, Minnesota, North Carolina, Ohio, Oregon, Wisconsin, and Wyoming.

The recall source does not specify what action consumers should take.

Written by software from the official notice below. Not reviewed by a lawyer.

Hazard

CGMP deviation: Product found to contain trace amounts of NMBA

Details from the source

Reason for recall: CGMP deviation: Product found to contain trace amounts of NMBA Distribution: AK, AZ, CA, CO, FL, KY, MA, MI, MN, NC, OH, OR, WI, WY Quantity: 576 bottles Lot/code info: 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

Source

Official record: FDA (Drug enforcement) ↗

Republished from the official source above; details can change — the source record controls.

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