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Recall Observatory FDA recall evidence

Drug product

Ranitidine Tablets, USP 150 mg, OTC, a.) 30 count bottle (NDC 68788-7078-03), b.) 60 count bottle (NDC 68788-7078-06), Mfg: Amneal Pharmaceuticals

D-0617-2020

December 02, 2019

Class II

Product summary

Firm
Preferred Pharmaceuticals, Inc
Event
Event 84422
Status
Terminated
Classification
Class II
Quantity
316 bottles
Official record key
drug-enforcement:D-0617-2020

Official wording

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

Code information: Lot #: I2519H, Exp. 12/20; I2719O, Exp. 12/20; J1419O, Exp. 12/20; J2819L, Exp. 12/20

Distribution pattern: CA, FL

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