Recall: D-0616-2020

Class II - Potentially Harmful

Class IIClassification

2019-11-22Initiated

OngoingStatus

Amneal Pharmaceuticals, Inc.Firm

Product

Ranitidine Tablets, USP 300 mg, 250-count bottles, NDC 53746-254-02.

Reason

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

Distribution

Product was distributed throughout the United States.

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