Ranitidine Syrup Oral Solution 15 mg/mL 6. fl. oz. (473 mL), NDC 65162-664-90.
FDA Recall #D-0614-2020 — Class II — November 22, 2019
Product Description
Ranitidine Syrup Oral Solution 15 mg/mL 6. fl. oz. (473 mL), NDC 65162-664-90.
Reason for Recall
CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API
Recalling Firm
Amneal Pharmaceuticals, Inc. — Brookhaven, NY
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Drugs
Product Quantity
N/A
Distribution
Product was distributed throughout the United States.
Code Information
06648001A 11/2019 06648003A 4/2020 06649001A 1/2021
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated