Home / Recalls / AuroMedics Pharma LLC / D-0528-2020

D-0528-2020 Class II Ongoing

Recalled by AuroMedics Pharma LLC — East Windsor, NJ

FDA drug recall D-0528-2020 was initiated by AuroMedics Pharma LLC on Nov 6, 2019 and is designated Class II. Reason for recall: CGMP Deviations: N-nitrosodimethylamine (NDMA) has been detected in Ranitidine tablets, capsules and syrups. The recall status is ongoing. Affected quantity: 134,160 bottles.

Recall Details

Product Type: Drugs
Report Date: Dec 4, 2019
Initiation Date: Nov 6, 2019
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 134,160 bottles

Product Description

Aurobindo Ranitidine Capsules 300 mg, 30-count bottle, Rx Only Distributed by: Aurobindo Pharma USA, Inc. 279 Princeton-Hightstown Road East Windsor, NJ 08520 NDC 59651-145-30

Reason for Recall

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

Distribution Pattern

nationwide

Code Information

RA3018001-A Jul 2020 RA3018002-A Jul-2020 RA3018003-A Jul 2020 RA3018004-A Aug 2020 RA3018005-A Aug 2020 RA3018006-A Aug 2020 RA3018007-A Sep 2020 RA3018008-A Sep 2020 RA3018009-A Sep 2020 RA3018010-A Oct 2020 RA3019001-A Jan 2021 RA3019002-A Jan 2021 RA3019003-A May 2021

Source

Dataset: openFDA drug recall enforcement reports
FDA record: This recall in openFDA (JSON)
Enforcement Report: Search FDA's Enforcement Report for D-0528-2020
openFDA file date: Nov 3, 2026
Loaded by RegDataLab: Nov 4, 2026

These dates say when openFDA published the data file and when RegDataLab last loaded it.

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