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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 80634

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

Open FDA event record

Event summary

Timeline bucket
July 27, 2018
Product types
Drug
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Bryant Ranch Prepack 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 80 mg tablets, 90-count bottles (NDC 63629-6922-2), 60-count bottles ( 63629-6922-3), 28-count bottles (63629-6922-4), Rx Only, Packaged by Bryant Ranch, Burbank, CA 91504.

D-1027-2018
Recall number
D-1027-2018
Initiated
July 27, 2018
Classification
Class II
Status
Terminated
Recalling firm
Bryant Ranch Prepack Inc.
Quantity
690 tablets

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 # 111158; Exp. 02/19

Distribution pattern

Product was distributed in HI, IN, and FL.

drug · product 2 of 3

Valsartan 320 mg tablets, 30-count bottles ( NDC 63629-6905-1), 90-count bottles (NDC 63629-6905-2), 28-count bottles (NDC 6362-96905-3), Rx Only, Packaged by Bryant Ranch, Burbank, CA 91504.

D-1028-2018
Recall number
D-1028-2018
Initiated
July 27, 2018
Classification
Class II
Status
Terminated
Recalling firm
Bryant Ranch Prepack Inc.
Quantity
990 tablets

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 # 114319; Exp. 10/18 Lot # 109004; Exp. 12/18

Distribution pattern

Product was distributed in HI, IN, and FL.

drug · product 3 of 3

Valsartan 320 mg tablets, 90-count bottles ( NDC 71335-0567-2), Rx Only, Packaged by Bryant Ranch, Burbank, CA 91504.

D-1029-2018
Recall number
D-1029-2018
Initiated
July 27, 2018
Classification
Class II
Status
Terminated
Recalling firm
Bryant Ranch Prepack Inc.
Quantity
90 tablets

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 # 120879; Exp 10/19

Distribution pattern

Product was distributed in HI, IN, and FL.