PharmiWeb.com - Global Pharma News & Resources
29-Aug-2019

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

WASHINGTON, Aug. 29, 2019 /PRNewswire/ -- https://www.cpsc.gov/Recalls/2019/Sandoz-Recalls-Losartan-Potassium-and-Ezetimibe-Prescription-Drug-Bottles-Due-to-Failure-to-Meet-ChildResistant-Closure-Requirements 

Recall Summary

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

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.

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

Units: About 636,000

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




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: Sandoz Inc., of Princeton, N.J.  

Manufactured in: Slovenia

About U.S. CPSC:
The U.S. Consumer Product Safety Commission is charged with protecting the public from unreasonable risks of injury or death associated with the use of thousands of types of consumer products under the agency's jurisdiction.  Deaths, injuries, and property damage from consumer product incidents cost the nation more than $1 trillion annually. CPSC is committed to protecting consumers and families from products that pose a fire, electrical, chemical or mechanical hazard. CPSC's work to ensure the safety of consumer products - such as toys, cribs, power tools, cigarette lighters and household chemicals – 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 more lifesaving information, follow us on Facebook, Instagram @USCPSC and Twitter @USCPSC or sign up to receive our e-mail alerts. To report a dangerous product or a product-related injury go online to www.SaferProducts.gov or call CPSC's Hotline at 800-638-2772 or teletypewriter at 301-595-7054 for the hearing impaired.

CPSC Consumer Information Hotline
Contact us at this toll-free number if you have questions about a recall:
800-638-2772 (TTY 301-595-7054)
Times: 8 a.m. – 5:30 p.m. ET; Messages can be left anytime
Call to get product safety and other agency information and to report unsafe products.

Media Contact
Please use the phone numbers below for all media requests.
Phone: 301-504-7908
Spanish: 301-504-7800

Recall Number: 19-194

View original content to download multimedia:http://www.prnewswire.com/news-releases/sandoz-recalls-losartan-potassium-and-ezetimibe-prescription-drug-bottles-due-to-failure-to-meet-child-resistant-closure-requirements-300909324.html

SOURCE U.S. Consumer Product Safety Commission

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

Editor Details

Last Updated: 29-Aug-2019