Drug product

Ranitidine Tablets, USP 150 mg, 1000-count bottles, NDC 53746-253-10.

D-0615-2020

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-0615-2020

Official wording

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

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

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