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D-0529-2020 Class II Ongoing

Recalled by AuroMedics Pharma LLC — East Windsor, NJ

FDA drug recall D-0529-2020 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: 19320 bottles.

Recall Details

Product Type: Drugs
Report Date: Dec 4, 2019
Initiation Date: Nov 6, 2019
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 19320 bottles

Product Description

Ranitidine Syrup (Ranitidine Oral Solution, USP), 15 mg/mL (75 mg/5mL) 474 mL bottle, Rx only Distributed by: Aurobindo Pharma USA Inc. 279 Princeton-Hightstown Road East Windsor, NJ 08520 Made in India NDC 65862-431-74

Reason for Recall

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

Distribution Pattern

nationwide

Code Information

UI1519001-A UI1519002-A UI1519003-A UI1519004-A

Source

Dataset: openFDA drug recall enforcement reports
FDA record: This recall in openFDA (JSON)
Enforcement Report: Search FDA's Enforcement Report for D-0529-2020
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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