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 |
NDC |
Lot |
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
SOURCE U.S. Consumer Product Safety Commission
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