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Recall Observatory FDA recall evidence

Drug product

Maximum Strength Acid Reducer, Cool Mint Ranitidine tablets, USP 150 mg, 40 tablets per bottle. [Brand, NDC] NDC Up & Up: 11673-950-58

D-1020-2020

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-1020-2020

Official wording

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

Code information: Lots: 9BE3161, 9CE3880, 9EE2500, 9FE2823, 9GE2656, 9HE3554, 9JE2676

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