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Recall Observatory FDA recall evidence

Drug product

Ranitidine, 150 mg Tablets, a) 7 count, b) 14 count, c) 20 count, d) 30 count, e) 60 count; Rx, Only, H.J. Harkins Company, Inc. dba Pharma Pac Grover Beach, CA 93433 NDC #s: 52959-0502-07, 52959-0502-14, 52959-0502-20, 52959-0502-30 and 52959-0502-60

D-0793-2020

January 06, 2020

Class II

Product summary

Firm
H J Harkins Company Inc dba Pharma Pac
Event
Event 84637
Status
Terminated
Classification
Class II
Quantity
7,212 tablets
Official record key
drug-enforcement:D-0793-2020

Official wording

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

Code information: Lot #s: RAN63KG Exp. 05/20, RAN64KG Exp. 10/20, RAN65KG Exp. 11/20, RAN66KG Exp. 05/21

Distribution pattern: Distributed to Physicians in the following states: CA, FL, NC, and SC.

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