Drug product

Regular Strength Acid Reducer, Ranitidine tablets, USP 75 mg, 80 tablets per bottle. [NDC: Brand] NDC Basic Care: 0113-7876-27; NDC CVS Health: 69842-293-27; NDC Leader: 70000-0375-2; NDC Up & Up: 11673-876-27; NDC Walgreens: 0363-1876-27

D-1014-2020

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-1014-2020

Official wording

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

Code information: Lots: 8CE1643, 8DE1370, 8DE1768, 8EE1560, 8FE1452, 8GE1341, 8HE1223, 8KE2832, 8KE2246, 8ME2725, 9AE2835, 9CE3378, 9DE2748, 9EE2637, 9FE2976, 9GE2795, 9GE3228, 9HE3617

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