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Recall Observatory FDA recall evidence

Drug product

Dr. Reddy's Ranitidine Tablets, USP 150 mg, 24 count bottles, NDC 55111-404-34 (OTC)

D-0182-2020

October 01, 2019

Class II

Product summary

Firm
Dr. Reddy's Laboratories, Inc.
Event
Event 83908
Status
Completed
Classification
Class II
Quantity
N/A
Official record key
drug-enforcement:D-0182-2020

Official wording

Reason: CGMP Deviations: Presence of NDMA impurity detected in product.

Code information: Batch Numbers: All lots within expiry.

Distribution pattern: Product was distributed to major distributors throughout the United States who may have further distributed the product.

Derived failure modes

  • Foreign material or chemical contamination

    reason.foreign_material_chemical_contamination · v1.0.0

    NDMA impurity
  • Manufacturing or process control

    reason.manufacturing_process_control · v1.0.0

    CGMP Deviations