Exact FDA event identifier

Event 74251

1 recalled-product record grouped only because every row carries this exact official event ID.

Event summary

Timeline bucket: May 13, 2016
Product types: Drug
Classifications: Class III
Statuses: Terminated
Recalling firm wording: Virtus Pharmaceuticals, Llc

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

Device root-cause evidence is not applicable to this event. No grouped product has the official product type device; this is not an unavailable-enrichment finding.

Complete imported group

Every recalled product in this event

1 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 1

Hyoscyamine Sulfate Sublingual Tablets, 0.125 mg, packaged in 100-count bottles, Rx only, Manufactured for: Virtus Pharmaceuticals OPCO II, LLC. Nashville, TN 37217. NDC 76439-0309-10

D-1044-2016

Recall number: D-1044-2016
Initiated: May 13, 2016
Classification: Class III
Status: Terminated
Recalling firm: Virtus Pharmaceuticals, Llc
Quantity: 24,614 bottles

App-derived interpretation

Foreign material or chemical contamination reason.foreign_material_chemical_contamination · v1.0.0

Chemical Contamination

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Chemical Contamination: Bottles may contain broken dessicants

Code information

Lot #: 638J011A

Distribution pattern

Nationwide & Puerto Rico.