Exact FDA event identifier

Event 88593

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

Event summary

Timeline bucket: September 02, 2021
Product types: Drug
Classifications: Class II
Statuses: Ongoing
Recalling firm wording: RISING PHARMACEUTICALS

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

Meclizine HCl Tablets, 25 mg, packaged in 100-count HDPE bottle, Distributed by: Rising Pharma Holdings, Inc. East Brunswick, NJ 08816, Manufactured by: Aurex laboratories LLC, East Windsor, NJ 08520, NDC 16571-752-01

D-0005-2022

Recall number: D-0005-2022
Initiated: September 02, 2021
Classification: Class II
Status: Ongoing
Recalling firm: RISING PHARMACEUTICALS
Quantity: 1,344 bottles

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0

Labeling: Incorrect

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Labeling: Incorrect Instructions

Code information

Lot # CB21024, Exp 2/2023

Distribution pattern

to be entered