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Recall Observatory FDA recall evidence

Drug product

Regular Strength Acid Reducer, Ranitidine tablets, USP 75 mg, 150 tablets per bottle. [NDC: Brand] NDC H.E.B.: 37808-876-47; NDC Equate: 49035-876-47

D-1015-2020

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-1015-2020

Official wording

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

Code information: Lots: 8CE1644, 8CE1645, 8DE1401, 8DE1402, 8DE1403, 8DE1769, 8DE1773, 8EE1561, 8EE1562, 8FE1453, 8FE1454, 8GE1342, 8HE1224, 8KE2248, 8KE2833, 8JE1918, 8KE2247, 8ME2727, 8ME2729, 9DE2750, 9AE2836, 9AE2837, 9CE3403, 9CE3404, 9DE2749, 9EE2638, 9FE2977, 9GE2796, 9GE3229

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