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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 90062

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

Open FDA event record

Event summary

Timeline bucket
April 14, 2022
Product types
Drug
Classifications
Class III
Statuses
Terminated
Recalling firm wording
Monarch PCM, 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

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

Phenobarbital Elixir, USP 20 mg/5 mL, 1 Pint (473 mL) bottles, Rx Only, Manufactured for: Westminster Pharmaceuticals, LLC Tampa, FL 33624, NDC 69367-172-16

D-0878-2022
Recall number
D-0878-2022
Initiated
April 14, 2022
Classification
Class III
Status
Terminated
Recalling firm
Monarch PCM, LLC
Quantity
15,730 bottles

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Does Not Meet USP or OTC Monograph: Product exceeds USP specification for alcohol content

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Does Not Meet USP or OTC Monograph: Product exceeds USP specification for alcohol content

Code information

Lot #: 20FP1569 Exp. Date 08/2022; 21FP1674 Exp. Date 02/2023; 21FP1831 Exp. Date 08/2023

Distribution pattern

TN only