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Recall Observatory FDA recall evidence

Drug product

Acetaminophen 500 mg tablet packaged in a) 30-count bottles ( NDC 52959-0002-30), b) 42-count bottles (NDC 52959-0002-42), c) 45-count bottles (NDC 52959-0002-45) and e) 50-count bottles (NDC 52959-0002-50) Repack: H.J. Harkins Co., Inc. Grover Beach, CA 93433

D-1005-2020

March 06, 2020

Class II

Product summary

Firm
H J Harkins Company Inc dba Pharma Pac
Event
Event 85158
Status
Terminated
Classification
Class II
Quantity
11,973 tablets
Official record key
drug-enforcement:D-1005-2020

Official wording

Reason: Presence of Foreign Tablets/Capsules: Complaint involving one Women's Prenatal dietary supplement tablet commingled in a bottle of Extra Strength Acetaminophen 500 mg contents 1000 count bottle

Code information: Lot #: AE00M, exp. date 08/2021

Distribution pattern: Nationwide within the United States

Derived failure modes

  • Foreign material or chemical contamination

    reason.foreign_material_chemical_contamination · v1.0.0

    Foreign Tablets