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Recall Observatory FDA recall evidence

Drug product

Regular Strength Acid Reducer, Ranitidine tablets, USP 75 mg, 160 tablets per bottle. [NDC: Brand] NDC CVS Health.: 69842-293-06

D-1016-2020

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-1016-2020

Official wording

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

Code information: Lots: 8FE1455, 8GE1343, 8HE1225, 8KE2834, 8KE2249, 8ME2730, 9AE2838, 9EE2639, 9FE2993

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