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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 80326

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

Open FDA event record

Event summary

Timeline bucket
June 15, 2018
Product types
Drug
Classifications
Class III
Statuses
Terminated
Recalling firm wording
Validus 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

2 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 2

Calcitriol Oral Solution, 1 mcg/mL, 15 mL bottle, Rx Only, Distributed by: Ranbaxy Pharmaceuticals Inc. Jacksonville, FL 32257 USA, NDC 63304-241-59

D-1170-2018
Recall number
D-1170-2018
Initiated
June 15, 2018
Classification
Class III
Status
Terminated
Quantity
7864 bottles

App-derived interpretation

Potency or specification failure reason.potency_specification_failure · v1.0.0
Subpotency

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Subpotency: lower than expected potency result was obtained at the 18 month stability time point.

Code information

RV1602RB, Exp 07/2019; RV1604RB, Exp 9/2019; RV1605RB, Exp 10/2019

Distribution pattern

U.S. nationwide

drug · product 2 of 2

Rocaltrol (calcitriol) Oral Solution, 1 mcg/mL, 15 mL bottle, Rx only, Distributed by: Validus Pharmaceuticals, LLC Parsippany, NJ 07054 USA, NDC 30698-911-15

D-1171-2018
Recall number
D-1171-2018
Initiated
June 15, 2018
Classification
Class III
Status
Terminated
Quantity
696 bottles

App-derived interpretation

Potency or specification failure reason.potency_specification_failure · v1.0.0
Subpotency

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Subpotency: lower than expected potency result was obtained at the 18 month stability time point.

Code information

RV1604, Exp 09/2019

Distribution pattern

U.S. nationwide