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Recall Observatory FDA recall evidence

Drug product

Ranitidine Syrup Oral Solution 15 mg/mL 6. fl. oz. (473 mL), NDC 65162-664-90.

D-0614-2020

November 22, 2019

Class II

Product summary

Firm
Amneal Pharmaceuticals, Inc.
Event
Event 84353
Status
Ongoing
Classification
Class II
Quantity
N/A
Official record key
drug-enforcement:D-0614-2020

Official wording

Reason: CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API

Code information: 06648001A 11/2019 06648003A 4/2020 06649001A 1/2021

Distribution pattern: Product was distributed throughout the United States.

Derived failure modes

  • Foreign material or chemical contamination

    reason.foreign_material_chemical_contamination · v1.0.0

    Impurity N-nitrosodimethylamine (NDMA
  • Manufacturing or process control

    reason.manufacturing_process_control · v1.0.0

    CGMP Deviations