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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 75146

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

Open FDA event record

Event summary

Timeline bucket
September 02, 2016
Product types
Drug
Classifications
Class I
Statuses
Terminated
Recalling firm wording
VIRTUS PHARMACEUTICALS OPCO II L

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

Hyoscyamine Sulfate, Sublingual Tablets, 0.125 mg, 100-count bottle, Rx only, Manufactured for: Virtus Pharmaceuticals OPCO II, LLC., Nashville, TN 37217, NDC 76439-309-10.

D-0212-2017
Recall number
D-0212-2017
Initiated
September 02, 2016
Classification
Class I
Status
Terminated
Quantity
94,643 bottles

App-derived interpretation

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

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Failed Content Uniformity Specifications: resulting in both superpotent and subpotent tablets.

Code information

Lot #: 30051601, 30051602*, 30051603, 30051604, Exp Jan-18, *some bottles contain the incorrect expiration date of Jan-28.

Distribution pattern

Nationwide and Puerto Rico

drug · product 2 of 3

Hyoscyamine Sulfate, Orally Disintegrating Tablets, 0.125 mg, 100-count bottles, Rx only, Manufactured for: Virtus Pharmaceuticals OPCO II, LLC., Nashville, TN 37217, NDC 76439-307-10.

D-0213-2017
Recall number
D-0213-2017
Initiated
September 02, 2016
Classification
Class I
Status
Terminated
Quantity
10,572 bottles

App-derived interpretation

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

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Failed Content Uniformity Specifications: resulting in both superpotent and subpotent tablets.

Code information

Lot #: 30011601, Exp 01/18

Distribution pattern

Nationwide and Puerto Rico

drug · product 3 of 3

Hyoscyamine Sulfate, USP Tablets, 0.125 mg, 100-count tablets per bottle, Rx only, Manufactured for: Virtus Pharmaceuticals OPCO II, LLC., Nashville, TN 37217, NDC 76439-308-10.

D-0214-2017
Recall number
D-0214-2017
Initiated
September 02, 2016
Classification
Class I
Status
Terminated
Quantity
24,444 bottles

App-derived interpretation

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

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Failed Content Uniformity Specifications: resulting in both superpotent and subpotent tablets.

Code information

Lot #: 30031601, 30031602, Exp 01/18

Distribution pattern

Nationwide and Puerto Rico

Field note

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