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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.

Manufactured In:
Slovenia
Distributor(s):

Sandoz Inc., of Princeton, N.J.

Recall number:
19-194
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About the U.S. CPSC
The U.S. Consumer Product Safety Commission (CPSC) is charged with protecting the public from unreasonable risks of injury or death associated with the use of thousands of types of consumer products. Deaths, injuries, and property damage from consumer product 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 deaths and injuries associated with consumer products over the past 40 years. Federal law bars any person from selling products subject to a publicly announced voluntary recall by a manufacturer or a mandatory recall ordered by the Commission.
For lifesaving information:
SaferProducts.gov