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Recall Observatory FDA recall evidence

Drug product

Maximum Strength Acid Reducer, Ranitidine tablets, USP 150 mg, 8 tablets. [NDC: Brand] NDC Good Sense:0113-0852-51; NDC Walgreens 0363-0852-51

D-1017-2020

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-1017-2020

Official wording

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

Code information: Lots: 8CE1429, 8CE1760, 9BE2907, 9DE3183, 9EE2900, 9JE2936

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