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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 85158

1 recalled-product record grouped only because every row carries this exact official event ID.

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Event summary

Timeline bucket
March 06, 2020
Product types
Drug
Classifications
Class II
Statuses
Terminated
Recalling firm wording
H J Harkins Company Inc dba Pharma Pac

Dossier provenance

Source snapshots represented here

  • openFDA Drug Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

1 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

drug · product 1 of 1

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
Recall number
D-1005-2020
Initiated
March 06, 2020
Classification
Class II
Status
Terminated
Quantity
11,973 tablets

App-derived interpretation

Foreign material or chemical contamination reason.foreign_material_chemical_contamination · v1.0.0
Foreign Tablets

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

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