Home / Recalls / AuroMedics Pharma LLC / D-0526-2020

D-0526-2020 Class II Ongoing

Recalled by AuroMedics Pharma LLC — East Windsor, NJ

FDA drug recall D-0526-2020 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: 69,696 bottles.

Recall Details

Product Type: Drugs
Report Date: Dec 4, 2019
Initiation Date: Nov 6, 2019
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 69,696 bottles

Product Description

DG Health Acid Reducer Ranitidine Tablets 150 mg, 8-count carton, Distributed by: Dolgencorp LLC 100 Mission Ridge Goodletville TN 37072 NDC 55910-092-79

Reason for Recall

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

Distribution Pattern

nationwide

Code Information

Lot # NBSB19001DA3; Exp FEB 2021

Source

Dataset: openFDA drug recall enforcement reports
FDA record: This recall in openFDA (JSON)
Enforcement Report: Search FDA's Enforcement Report for D-0526-2020
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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