Home / Recalls / Granules India Limited / D-0632-2020

D-0632-2020 Class II Ongoing

Recalled by Granules India Limited — Qutbullapur Mandal, Ranga Redd, N/A

FDA drug recall D-0632-2020 was initiated by Granules India Limited on Dec 13, 2019 and is designated Class II. Reason for recall: CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API The recall status is ongoing. Affected quantity: 23,090,000 tablets.

Recall Details

Product Type: Drugs
Report Date: Jan 8, 2020
Initiation Date: Dec 13, 2019
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 23,090,000 tablets

Product Description

RANITIDINE TABLETS, USP 150mg, 10,000-count bag, Country of Origin: INDIA NDC 62207-773-32

Reason for Recall

CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API

Distribution Pattern

OR, NY, NJ

Code Information

7730001A, 7730002A, 7730003A, 7730004A, 7730005A, 7730006A, 7730007A, 7730008A, 7730009A, 7730010A, 7730011A and 7730012A

Source

Dataset: openFDA drug recall enforcement reports
FDA record: This recall in openFDA (JSON)
Enforcement Report: Search FDA's Enforcement Report for D-0632-2020
openFDA file date: Nov 10, 2026
Loaded by RegDataLab: Nov 11, 2026

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