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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 80701

3 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
July 30, 2018
Product types
Drug
Classifications
Class II
Statuses
Terminated
Recalling firm wording
NuCare Pharmaceuticals Inc

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

3 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 3

Valsartan/HCTZ 160/12.5 mg Tablets, 90-count jar, Rx Only, Packaged by NuCare Pharmaceuticals, Inc., Orange, CA 92867, NDC 68071-4311-9

D-1037-2018
Recall number
D-1037-2018
Initiated
July 30, 2018
Classification
Class II
Status
Terminated
Quantity
N/A

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
CGMP Deviations

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.

Code information

Lot # U01779; Exp. 04/30/2019

Distribution pattern

Distributed to three customers in Fl and CA

drug · product 2 of 3

Valsartan/HCTZ 160/25mg Tablets, 30-count jar, Rx Only, Packaged by NuCare Pharmaceuticals, Inc., Orange, CA 92867,

D-1038-2018
Recall number
D-1038-2018
Initiated
July 30, 2018
Classification
Class II
Status
Terminated
Quantity
N/A

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
CGMP Deviations

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.

Code information

Lot # T11443; Exp. 02/28/2019

Distribution pattern

Distributed to three customers in Fl and CA

drug · product 3 of 3

Valsartan/HCTZ 320/25mg Tablets, 30-count jar, Rx Only, Packaged by NuCare Pharmaceuticals, Inc., Orange, CA 92867, NDC 68071-4183-3

D-1039-2018
Recall number
D-1039-2018
Initiated
July 30, 2018
Classification
Class II
Status
Terminated
Quantity
N/A

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
CGMP Deviations

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.

Code information

Lot # T11577; Exp. 06/30/2019

Distribution pattern

Distributed to three customers in Fl and CA