Drug recall D-0527-2020

Class II Ongoing reported Dec 4, 2019

Product

Aurobindo Ranitidine Caspules 150 mg, 60-count bottle, Rx Only Distributed by: Aurobindo Pharma USA, Inc. 279 Princeton-Hightstown Road East Windsor, NJ 08520 NDC 59651-144-60

Reason for recall

CGMP Deviations: N-nitrosodimethylamine (NDMA) has been detected in Ranitidine tablets, capsules and syrups.

Lots and codes

RA1518001-A Jul 2020 RA1518002-A Jul 2020 RA1518005-B Aug 2020 RA1518006-A Aug 2020 RA1519003-A May 2021

Recall details

Recalling firm
AuroMedics Pharma LLC, East Windsor, NJ
Quantity
45,456 bottles
Distribution
nationwide
Type
Voluntary: Firm initiated
Recall initiated
November 6, 2019