Ranitidine Tablets, USP 300 mg, 250-count bottles, NDC 53746-254-02.
FDA Recall #D-0616-2020 — Class II — November 22, 2019
Product Description
Ranitidine Tablets, USP 300 mg, 250-count bottles, NDC 53746-254-02.
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
HB04118A 2/2020 HB04218A 2/2020 HB04318A 2/2020 HB04418A 2/2020 HF13518A 6/2020 HF13618A 6/2020 HF13718A 6/2020 HF13818A 6/2020 HK02818A 9/2020 HK02918A 9/2020 HK03018A 9/2020 HK03118A 9/2020 HL08418A 11/2020 HL08518A 11/2020 HL08618A 11/2020 HL08718A 11/2020 HB01419A 1/2021 HB05619A 1/2021 HB05719A 1/2021 HB05819A 1/2021 HB05919A 1/2021 HB06019A 1/2021 HB06119A 1/2021
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated