Recall Date: August 29, 2019
Recall Number: 19-194
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.”
Pictures available here: https://www.cpsc.gov/Recalls/2019/Sandoz-Recalls-Losartan-Potassium-and-Ezetimibe-Prescription-Drug-Bottles-Due-to-Failure-to-Meet-ChildResistant-Closure-Requirements
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 | 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 30 count bottle |
0781-5701-31 | HV9471 | Feb-2020 |
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
