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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 92324

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

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Event summary

Timeline bucket
April 20, 2023
Product types
Drug
Classifications
Class I
Statuses
Terminated
Recalling firm wording
Novis PR, LLC dba Kramer Novis

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

G-Supress DX (Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl) Pediatric Drops Cough Suppressant Expectorant Nasal Decongestant, Cherry Flavor Sugar & Alcohol Free, packaged in a bottle Net Content: 30 mL (1 oz.) further packaged in a carton, Manufactured in the USA for Kramer Novis, San Juan, PR 00917, NDC 52083-655-01

D-0868-2023
Recall number
D-0868-2023
Initiated
April 20, 2023
Classification
Class I
Status
Terminated
Quantity
9077 bottles

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Product mix-up: incorrect product was found inside the G-Supress DX product carton.

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Product mix-up: incorrect product was found inside the G-Supress DX product carton.

Code information

Lot: D20911, Exp. Oct/25

Distribution pattern

Puerto Rico