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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 80674

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

Open FDA event record

Event summary

Timeline bucket
July 26, 2018
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

Valsartan tablets 160 mg, 90-count bottle, Rx Only, Repackaged by H.J. Harkins Co, Inc. Grover Beach, CA 93433, NDC 43547-0369-09. Tablet is yellow, capsule-shaped, biconvex, film-coated tablets debossed with 343 on one side and HH on the other side.

D-1022-2018
Recall number
D-1022-2018
Initiated
July 26, 2018
Classification
Class II
Status
Terminated
Quantity
540 tablets

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Carcinogen impurity detected in API used to manufacture drug product.

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Carcinogen impurity detected in API used to manufacture drug product.

Code information

Lot # VSA000OV Manufacturer's original lot # 343B17015, exp date 02/19 NDC 43547-0369-09

Distribution pattern

Product was distributed to a physician's office.