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

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