Home / Recalls / AuroMedics Pharma LLC / D-0527-2020

D-0527-2020 Class II Ongoing

Recalled by AuroMedics Pharma LLC — East Windsor, NJ

Recall Details

Product Type
Drugs
Report Date
December 4, 2019
Initiation Date
November 6, 2019
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
45,456 bottles

Product Description

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.

Distribution Pattern

nationwide

Code Information

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

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