Recall: D-0632-2020

Class II - Potentially Harmful

Class IIClassification

2019-12-13Initiated

OngoingStatus

Granules India LimitedFirm

Product

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

Reason

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

Distribution

OR, NY, NJ

Source: FDA drug enforcement report via openFDA (Voluntary: Firm initiated). If you take this product, talk to your pharmacist or doctor before stopping it.