FDA Drug Class II — Moderate

Ranitidine Syrup Oral Solution 15 mg/mL 6. fl. oz. (473 mL), NDC 65162-664-90.

Hazard

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

Products

Ranitidine Syrup Oral Solution 15 mg/mL 6. fl. oz. (473 mL), NDC 65162-664-90.
Brand
Amneal Pharmaceuticals, Inc.
UPC
06648001A 11/2019 06648003A 4/2020 06649001A 1/2021

Units Affected

N/A