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Recall 2018-108: Novartis - Entresto & Zofran - NYC - Consumer


                                                                           Recall 2018-108: Novartis - Entresto & Zofran - NYC - Consumer

URGENT!!!            DRUG RECALL!!!            URGENT!!!

NDC                       Description                                                    Lot #                 Expiration Date

00078065935         ENTRESTO TAB 24/26MG UD    100           F0009               08/31/2018
                                                                                                      F0010              11/30/2018
                                                                                                      FX000003        09/30/2019       
                                                                                                      FX000004        04/30/2020
                                                                                                      FX000005        04/30/2020
                                                                                                      F0007               07/31/2018
00078077735         ENTRESTO TAB 49/51MG UD    100           FX000001         12/31/2019
                                                                                                      F0004               10/31/2018
                                                                                                      F0005               08/31/2019
                                                                                                      F0006               10/31/2019

00078069635         ENTRESTO TAB 97/103MG UD   100          FX000002          03/31/2020
                                                                                                      F0004               10/31/2018
                                                                                                      F0005               12/31/2018
                                                                                                      F0006               12/31/2019
                                                                                                      F0007                02/29/2020
        
00078067919         ZOFRAN ODT TAB 4MG                              1657088            12/31/2019

00078068019         ZOFRAN ODT TAB 8MG UD                        1641546            10/31/2019       


Novartis is voluntarily recalling the above items/lots due to the products not being packaged in child-resistant packaging posing a risk of harm if the tablets are swallowed by children. This action is not a result of any quality or safety concerns with the medications for their intended use.  This recall is to the Consumer level. Affected product started shipping September 7, 2016.

Patient Action:
The quality of the medications have not been compromised, so you should continue taking your medicine as directed by your physician. However, due to the risk of harm to children, please immediately secure this medicine so that it is out of the sight and reach of children.

Please order a child resistant pouch in which to store your blister cards by calling Novartis at 888-NOW-NOVA (888-669-6682) between 8 am - 8 pm ET Monday thru Friday, or 9 am - 6 pm ET Saturday and Sunday. You may also visit https://www.pharma.us.novartis.com/recall-zofran-and-entresto-packages for more information

This recall is being conducted with the knowledge of the CPSC and FDA.

Contact:

Novartis: Novartis Customer Service Service 888-669-6682