Drug product

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

D-0616-2020

November 22, 2019

Class II

Product summary

Firm: Amneal Pharmaceuticals, Inc.
Event: Event 84353
Status: Ongoing
Classification: Class II
Quantity: N/A
Official record key: drug-enforcement:D-0616-2020

Official wording

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

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

Distribution pattern: Product was distributed throughout the United States.

Derived failure modes

Foreign material or chemical contamination
reason.foreign_material_chemical_contamination · v1.0.0

Impurity N-nitrosodimethylamine (NDMA
Manufacturing or process control
reason.manufacturing_process_control · v1.0.0

CGMP Deviations