CPSCGeneral Alert

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

Veröffentlicht: 29. August 2019Rückruf-ID: 19194Kategorie: VerbraucherprodukteLand: Vereinigte Staaten
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Mitteilung übersetzenTranslate notice text, hazard warnings, and descriptions into any supported language.

Grund für den Rückruf / Gefahr

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

Produktbeschreibung & Identifikation

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

Betroffene Produkte

Losartan Potassium and Ezetimibe prescription drug bottles

Additional Source Details

FieldValue
U R Lhttps://www.cpsc.gov/Recalls/2019/Sandoz-Recalls-Losartan-Potassium-and-Ezetimibe-Prescription-Drug-Bottles-Due-to-Failure-to-Meet-ChildResistant-Closure-Requirements
TitleSandoz Recalls Losartan Potassium and Ezetimibe Prescription Drug Bottles Due to Failure to Meet Child-Resistant Closure Requirements
Images › 1 › U R Lhttps://www.cpsc.gov/s3fs-public/1577_1.jpeg
Images › 1 › CaptionEzetimibe 10mg Tablets 30 count bottle
Images › 2 › U R Lhttps://www.cpsc.gov/s3fs-public/1577_2.jpeg
Images › 2 › CaptionEzetimibe 10mg Tablets 90 count bottle
Images › 3 › U R Lhttps://www.cpsc.gov/s3fs-public/1577_3.jpeg
Images › 3 › CaptionLosartan Potassium 50mg Tablets 30 count bottle
Images › 4 › U R Lhttps://www.cpsc.gov/s3fs-public/1577_4.jpeg
Images › 4 › CaptionLot and Expiration Date Location
Hazards › NameThe prescription drug packaging is not child resistant as required by the Poison Prevention Packaging Act, posing a poisoning risk if swallowed by children.
Injuries › NameNone Reported
Products › NameLosartan Potassium and Ezetimibe prescription drug bottles
Products › Number Of UnitsAbout 636,000
Recall I D8651
Remedies › NameConsumers 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.
Retailers › NameClinics 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.
Recall Date2019-08-29T00:00:00
DescriptionThis 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
Distributors › NameSandoz Inc., of Princeton, N.J.
Recall Number19194
Remedy Options › OptionReplace
Consumer ContactSandoz 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.”
Last Publish Date2019-08-29T00:00:00
Manufacturer Countries › CountrySlovenia

Consumer Action Protocol: What You Should Do Immediately

Safety Steps
1Verify Product Identifiers

Check the model number, serial number, and date stamp on the rating label on the back or underside of the product.

2Isolate & Discontinue Use

Immediately discontinue using the product. Unplug electrical items and keep juvenile items out of reach of children.

3Claim Free Statutory Remedy

Under statutory consumer protection rules, consumers are entitled to a full refund, certified replacement, or free repair kit without needing the original sales receipt.

4Report Adverse Incidents

If you suffered an injury, illness, or property damage from this product, file an official incident report with regulatory authorities (CPSC).

Your Legal Rights as a Consumer

Recalls are legally binding corrective safety actions overseen by statutory government bodies. Recalling entities are legally prohibited from charging consumers for official safety remedies. If a retailer or dealership refuses your recall remedy, notify the issuing regulatory agency immediately.

Frequently Asked Questions About This Recall

FAQ Guide

Q1:What should I do immediately if I own or bought Sandoz Recalls Losartan Potassium and Ezetimibe Prescription Drug Bottles Due to Failure to Meet Child-Resistant Clos...?

Immediately stop using the product and keep it out of reach of children. Disconnect power if electrical, and do not attempt makeshift home repairs.

Q2:Can I get a full refund or free repair for this recall?

Yes. Recalling manufacturers and retail merchants are required under consumer protection regulations to offer a statutory remedy—typically a full refund, certified repair kit, or replacement unit.

Q3:Do I need my original sales receipt to claim a remedy or refund?

In most recall cases, no receipt is required. Because safety recalls are matters of public health and statutory compliance, retailers and manufacturers routinely issue refunds, store credit, or replacement kits upon presentation of the affected product or lot code.

Q4:Where can I verify official information for this safety alert?

This safety alert is aggregated directly from official regulatory agency records (CPSC). You can click the 'Official Agency Alert' link on this page to view the primary government notice and contact the manufacturer directly.

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