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Recall Observatory FDA recall evidence

Drug product

Maximum Strength Acid Reducer, Cool Mint Ranitidine tablets, USP 150 mg, 95 tablets per bottle. [Brand, NDC] NDC Basic Care: 0113-7950-01; NDC CVS Health: 59779-950-01

D-1027-2020

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-1027-2020

Official wording

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

Code information: Lots: 8BE1032, 8BE1486, 8CE1638, 8DE1361, 8DE1612, 8FE1354, 8GE1737, 8HE1654, 8JE2237, 8KE2726, 8LE2369, 8ME2645, 9AE2777, 9CE3315, 9DE2720, 9EE2578, 9FE2956, 9GE2698, 9GE3202

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