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

Recall Details

Product Type
Drugs
Report Date
January 8, 2020
Initiation Date
December 13, 2019
Termination Date
N/A
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