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Sandoz Recalls Losartan Potassium and Ezetimibe Prescription Drug Bottles Due to Failure to Meet Child-Resistant Closure Requirements

  • Ezetimibe 10mg Tablets 30 count bottle
  • Ezetimibe 10mg Tablets 90 count bottle
  • Losartan Potassium 50mg Tablets 30 count bottle
  • Lot and Expiration Date Location
Name of Product:
Losartan Potassium and Ezetimibe prescription drug bottles
Hazard:

The prescription drug packaging is not child resistant as required by the Poison Prevention Packaging Act, posing a poisoning risk if swallowed by children.

Remedy:
Replace
Recall Date:
August 29, 2019
Units:
About 636,000
Consumer Contact

Sandoz at 800-525-8747 from 8:30 a.m. to 5 p.m. ET Monday to Friday or online at www.us.sandoz.com and click on “Patients and Customers” then “Product Safety Notices.”

Recall Details

Description:

This recall involves bottles of prescription medications Losartan Potassium and Ezetimibe from Sandoz with certain lot numbers.  The recalled bottles have “Sandoz,” the name of the medication, dosage, and NDC on the front of the bottle labels and the lot number and expiration date on the side of the bottle labels.  The recall includes the following:

 

Recalled Prescription Drugs

NDC Numbers

Lot Numbers

Expiration Date

Ezetimibe 10mg Tablets

0781-5690-31

JE4491

Aug-2020

30 count bottle

 

JE4492

Aug-2020

   

JE4493

Aug-2020

   

JE4495

Aug-2020

   

JG0308

Sep-2020

   

JG0310

Sep-2020

   

JG0311

Sep-2020

   

JG0312

Sep-2020

   

JG5061

Sep-2020

   

JG5063

Sep-2020

   

JK8921

Oct-2020

   

JK8922

Oct-2020

   

JK8923

Oct-2020

   

JK8924

Oct-2020

   

JL5535

Oct-2020

   

JM2253

Oct-2020

   

JM2254

Oct-2020

   

JM2255

Oct-2020

   

JM2257

Oct-2020

   

JM2258

Oct-2020

   

JM2259

Oct-2020

   

JM5986

Oct-2020

   

JM5987

Oct-2020

Ezetimibe 10mg Tablets

0781-5690-92

JE4481

Aug-2020

90 count bottle

 

JG0249

Sep-2020

   

JK8989

Oct-2020

   

JN0764

Jan-2021

Losartan Potassium 50mg Tablets

0781-5701-31

HV9471

Feb-2020

30 count bottle

     
Remedy:

Consumers should immediately secure the medications to keep them out of the sight and reach of children and contact Sandoz for a free replacement child resistant bottle cap. Once the medication is secured, consumers can continue to use the medication as directed.

Incidents/Injuries:

None Reported

Sold At:
Clinics and pharmacies nationwide as a prescribed medicine from July 2018 through August 2019. The container was included in the price of the medication, which varied based on quantities prescribed, health insurance terms and other factors.
Distributor(s):
Sandoz Inc., of Princeton, N.J.
Manufactured In:
Slovenia
Recall number:
19-194

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The U.S. Consumer Product Safety Commission (CPSC) is charged with protecting the public from unreasonable risk of injury or death associated with the use of thousands of types of consumer products. Deaths, injuries, and property damage from consumer product-related incidents cost the nation more than $1 trillion annually. CPSC's work to ensure the safety of consumer products has contributed to a decline in the rate of injuries associated with consumer products over the past 50 years.

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