Recall 2019-158: Sandoz - Ranitidine - NYC - Consumer


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

Product Name NDC Number  Lot Number Expiration Date
RANITIDINE 150 MG CAPSULE 500 count 00781285505 HD1862 04/30/2020
RANITIDINE 150 MG CAPSULE 500 count 00781285505 HP9438 09/30/2020
RANITIDINE 150 MG CAPSULE 500 count 00781285505 HP9439 09/30/2020
RANITIDINE 150 MG CAPSULE 500 count 00781285505 HP9440 09/30/2020
RANITIDINE 150 MG CAPSULE 60 count 00781285560 HC9266 04/30/2020
RANITIDINE 150 MG CAPSULE 60 count 00781285560 HD1865 04/30/2020
RANITIDINE 150 MG CAPSULE 60 count 00781285560 HP9441 09/30/2020
RANITIDINE 150 MG CAPSULE 60 count 00781285560 JK7994 08/31/2021
RANITIDINE 150 MG CAPSULE 60 count 00781285560 JK8659 08/31/2021
RANITIDINE 300 MG CAPSULE 30 count 00781286531 HD8625 04/30/2020
RANITIDINE 300 MG CAPSULE 30 count 00781286531 HD9275 04/30/2020
RANITIDINE 300 MG CAPSULE 30 count 00781286531 HU2207 08/31/2020
RANITIDINE 300 MG CAPSULE 30 count 00781286531 HX6676 03/31/2021
RANITIDINE 300 MG CAPSULE 30 count 00781286531 HX6677 03/31/2021

Sandoz is voluntarily recalling the above items/lots because of confirmed contamination with N-Nitrosodimethylamine (NDMA) above levels established by the FDA in batches of Sandoz Ranitidine Hydrochloride Capsules. To date, Sandoz has not yet received any reports of adverse events related to use of the product as part of this recall. This recall is to the Consumer level. Affected product started shipping April 19, 2017.

Consumers are asked to continue taking their medication and speak to their physician or pharmacist on alternate healthcare treatment options.
 
Consumers with questions regarding this recall can contact Sandoz at 1-800-525-8747 option # between 8:30am - 5:00pm Monday - Friday EST or www.us.sandoz.com for more information. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product.

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

Contact:

Customer Service: Sandoz Sandoz 800-525-8747