Drug product

Regular Strength Acid Reducer, Ranitidine tablets, USP 75 mg, 60 tablets per bottle. [NDC: Brand] NDC Health Mart: 62011-0283-2; NDC Major: 0904-6715-52; NDC Meijer: 41250-252-72; NDC Sunmark: 49348-136-12;

D-1013-2020

October 23, 2019

Class II

Product summary

Firm: Perrigo Company PLC
Event: Event 84127
Status: Terminated
Classification: Class II
Quantity: Unavailable
Official record key: drug-enforcement:D-1013-2020

Official wording

Reason: CGMP Deviation; Possible contamination with impurity N-nitrosodimethylamine.

Code information: Lots: 8DE1367, 8EE1559, 8FE1451, 8GE1340, 8HE1222, 8KE2831, 8JE1917, 8KE2245 , 8ME2724, 9AE2831, 9DE2747, 9CE3339, 9EE2636, 9FE2971, 9GE2793, 9GE3220

Distribution pattern: Nationwide USA

Derived failure modes

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

impurity N-nitrosodimethylamine
Manufacturing or process control
reason.manufacturing_process_control · v1.0.0

CGMP Deviation