PlainRecalls
FDA Drug Moderate Class II Terminated

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

Reported: May 5, 2021 Initiated: March 8, 2019 #D-0341-2021

Product Description

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

Details

Units Affected
576 bottles
Distribution
AK, AZ, CA, CO, FL, KY, MA, MI, MN, NC, OH, OR, WI, WY
Location
Oklahoma City, OK

Frequently Asked Questions

What product was recalled?
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. Recalled by PD-Rx Pharmaceuticals, Inc.. Units affected: 576 bottles.
Why was this product recalled?
CGMP deviation: Product found to contain trace amounts of NMBA
Which agency issued this recall?
This recall was issued by the FDA Drug on May 5, 2021. Severity: Moderate. Recall number: D-0341-2021.