Recall 2019-142 Sandoz - Ezetimibe and Losartan - Consumer


URGENT!!!            SAFETY RECALL/CORRECTIVE ACTION!!!            URGENT!!!


Description

Lot #

Exp Date

NDC

EZETIMIBE TAB 10MG SAN     30@

JE4491

08/31/2020

00781569031

 

JE4492

08/31/2020

 

 

JE4493

08/31/2020

 

 

JE4495

08/31/2020

 

 

JG0308

09/30/2020

 

 

JG0310

09/30/2020

 

 

JG0311

09/30/2020

 

 

JG0312

09/30/2020

 

 

JG5061

09/30/2020

 

 

JG5063

09/30/2020

 

 

JK8921

10/31/2020

 

 

JK8922

10/31/2020

 

 

JK8923

10/31/2020

 

 

JK8924

10/31/2020

 

 

JL5535

10/31/2020

 

 

JM2253

10/31/2020

 

 

JM2254

10/31/2020

 

 

JM2255

10/31/2020

 

 

JM2257

10/31/2020

 

 

JM2258

10/31/2020

 

 

JM2259

10/31/2020

 

 

JM5986

10/31/2020

 

 

JM5987

10/31/2020

 

EZETIMIBE TAB 10MG SAN     90@

JE4481 

08/31/2020

00781569092

 

JK8989 

10/31/2020

 

 

JG0249 

09/30/2020

 

 

JN0764 

01/31/2021

 

LOSARTAN TAB 50MG   SAN    30@

HV9471

02/29/2020

00781570131



Sandoz is voluntarily implementing a CPSC-approved corrective action for the above items/lots due to the cap and bottle combination for these items being not child resistant. 

This action is not a result of any quality or safety concerns with the medications for their intended use.  This action plan should be carried out to the Consumer level.  Affected product started shipping June 27, 2018.

Patients should immediately check their product to see if their product is impacted by this event.  If their product is impacted they should immediately secure the medication out of the sight and reach of children. 

Patients should continue taking their medications as directed by their physician as the quality of the products have not been compromised.  

Patients need to call Sandoz toll free at 800-525-8747 from 8:30am - 5:00 pm EST Monday through Friday to request a new bottle cap.  Patients need to provide the following information for the replacement cap:

• Patient name, address, and telephone number
• Number of Ezetimibe Tablet and/or Losartan Potassium Tablet bottles in possession

This recall/corrective action is being conducted with the knowledge of the US Consumer Product Safety Commission ("CPSC") and FDA.

Contact:

Sandoz Pharmaceuticals: Sandoz Customer Service 800-525-8747