UPDATE: Recall 2019-167B Dr. Reddy's - Ranitidine - NYC - Consumer


URGENT!!! UPDATED NDC NUMBERS !!! URGENT

Description NDC Lot Number Exp Date
RANITIDINE TAB 150MG 55111040434 79L800541F 05/31/2020
RANITIDINE TAB 150MG 55111040434 79L800851D 09/30/2020
RANITIDINE TAB 150MG 55111040434 79L900008C 12/31/2020
RANITIDINE TAB 150MG 55111040434 L9L800679D 06/30/2020
RANITIDINE TAB 150MG 55111040434 L9L800854C 09/30/2020
RANITIDINE TAB 75MG  55111013160 79L800500C 04/30/2020
RANITIDINE TAB 75MG  55111013160 79L800967C 11/30/2020
RANITIDINE TAB 75MG  55111013160 79L800787C 08/31/2020

Dr. Reddy's is voluntarily recalling the above items/lots due to USFDA alert notice regarding low levels of N-nitrosodimethylamine (NDMA) impurity found in some samples of Ranitidine medicines, subsequent preliminary test results at Dr. Reddy's laboratories for some for the Drug Substance (API) lots used in Drug Product manufacturing have levels of NDMA that could potentially contribute to elevated levels of NDMA in Drug Product with respect to the maximum allowable daily limit.

This recall was expanded to the consumer level for prescription products based on the USFDA's recent feedback that all NDMA-related prescription drug recalls are to be expanded to the consumer level. Affected product started shipping January 2017.

Consumers should return their impacted product to their pharmacy for credit or replacement. If you have any questions, please contact Dr. Reddy's Medical Information Call Center at 1-888-375-3784 (1-888-DRL-DRUG).

Patients should contact their healthcare provided 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:

Medical Information: Dr.Reddy's Call Center 888-375-3784