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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 94738

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

Open FDA event record

Event summary

Timeline bucket
May 31, 2024
Product types
Drug
Classifications
Class II
Statuses
Terminated
Recalling firm wording
RemedyRepack 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

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

Phenazopyridine HCl, 100mg tablets, 6 count bottles, Rx Only, Repackaged by: RemedyRepack, Inc., Indiana, PA NDC#: 70518-0218-00, Source NDC: 75826-0114-10 MFG: Winder Laboratories, LLC, Winder, GA

D-0549-2024
Recall number
D-0549-2024
Initiated
May 31, 2024
Classification
Class II
Status
Terminated
Recalling firm
RemedyRepack Inc.
Quantity
8 bottles

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Product Mix Up. A bottle labeled as Phenazopyridine HCl tablets USP 100 mg contained Phenobarbital tablets 16.2 mg.

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Product Mix Up. A bottle labeled as Phenazopyridine HCl tablets USP 100 mg contained Phenobarbital tablets 16.2 mg.

Code information

Lot # B2906961-042524, exp. date 02/26/2027

Distribution pattern

Product was distributed to one medical facility.