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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 87093

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

Open FDA event record

Event summary

Timeline bucket
January 07, 2021
Product types
Drug
Classifications
Class III
Statuses
Terminated
Recalling firm wording
Bausch Health Companies, 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

Mephyton (phytonadione) Tablets 5mg, 100-count bottle, Rx Only, Manufactured for: Valeant Pharmaceuticals North America, LLC Bridgewater, NJ 08807 USA NDC 0187-1704-05

D-0243-2021
Recall number
D-0243-2021
Initiated
January 07, 2021
Classification
Class III
Status
Terminated
Quantity
895 bottles

App-derived interpretation

Potency or specification failure reason.potency_specification_failure · v1.0.0
Out of specification

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Failed Impurities/Degradation Specifications:Out of specification during the 24 month stability testing of Impurity D.

Code information

Lot: 18L092P, Exp 05/2021

Distribution pattern

Distributed Nationwide in the USA

drug · product 2 of 2

Phytonadione Tablets 5mg, 30-count bottle, Rx Only, Manufactured For: Oceanside Pharmaceuticals, a division of Valeant Pharmaceuticals North America LLC Bridgewater, NJ 08807 USA NDC 68682-170-30

D-0244-2021
Recall number
D-0244-2021
Initiated
January 07, 2021
Classification
Class III
Status
Terminated
Quantity
14,089 bottles

App-derived interpretation

Potency or specification failure reason.potency_specification_failure · v1.0.0
Out of specification

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Failed Impurities/Degradation Specifications:Out of specification during the 24 month stability testing of Impurity D.

Code information

Lot: 18L091P, Exp 05/2021

Distribution pattern

Distributed Nationwide in the USA