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Class II · ModerateRecall completed

Losartan Potassium

Could cause temporary or reversible harm; serious harm is unlikely.

Does this affect you?
Check your lot numberLots: 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
Where it was soldAK, AZ, CA, CO, FL, KY, MA, MI, MN, NC, OH, OR, WI, WY
Find the lot number printed on your box or bottle. If it matches — and you take this medicine — call your pharmacist. Don't stop a prescribed medicine on your own.

What happened

CGMP deviation: Product found to contain trace amounts of NMBA

What to do

  1. Check the lot number and expiry on your medicine against the recall above.
  2. Talk to your pharmacist or doctor before changing anything — don't stop on your own.
  3. Report any problems to FDA MedWatch (1-800-FDA-1088 or fda.gov/medwatch).

Who makes it

Made byPD-Rx Pharmaceuticals, Inc.
Brand nameLOSARTAN POTASSIUM
Generic nameLOSARTAN POTASSIUM
Active ingredient(s)LOSARTAN POTASSIUM
Distributed by / forPD-Rx Pharmaceuticals, Inc.
NDC43063-854-60
Show the full FDA record
Full product labelLosartan 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
Recalling firmPD-Rx Pharmaceuticals, Inc.
DistributionAK, AZ, CA, CO, FL, KY, MA, MI, MN, NC, OH, OR, WI, WY
Quantity576 bottles
Recall initiated2019-03-08
Report date2021-05-05
Recall completed2021-06-16
Recall numberD-0341-2021
ClassificationClass II
FDA statusTerminated
Origin on fileOklahoma City OK United States

Related

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Source: U.S. FDA enforcement database (openFDA). Look this up on the official FDA recalls site ↗

This is public FDA recall information, not medical advice. A recall does not always mean your specific bottle is affected. Never stop a prescribed medicine without asking your pharmacist or doctor.