Ranitidine Tablets, USP 150 mg, 1000-count bottles, NDC 53746-253-10.
FDA Recall #D-0615-2020 — Class II — November 22, 2019
Product Description
Ranitidine Tablets, USP 150 mg, 1000-count bottles, NDC 53746-253-10.
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
HB03718A 3/2020 HB03818A 3/2020 HB03918A 3/2020 HB04018A 3/2020 HC01618A 3/2020 HC14618A 5/2020 HC14718A 5/2020 HC14818A 5/2020 HC14918A 5/2020 HC15018A 5/2020 HK02318A 9/2020 HK02418A 9/2020 HK02518A 9/2020 HK02618A 9/2020 HD03119A 3/2021 HD03219A 3/2021 HE03119A 4/2021 HE03219A 4/2021
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated