Exact FDA event identifier

Event 87817

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

Event summary

Timeline bucket: April 29, 2021
Product types: Drug
Classifications: Class III
Statuses: Terminated
Recalling firm wording: Ascend Laboratories 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

Olmesartan Medoxomil Tablets, USP, 20 mg, Rx Only, 30 Tablets, Manufactured by Alkem Laboratories Ltd, Mumbai, 400 013. INDIA, Distributed by: Ascend Laboratories LLC, Parsippany, NJ, 07054, NDC 67877-446-30.

D-0392-2021

Recall number: D-0392-2021
Initiated: April 29, 2021
Classification: Class III
Status: Terminated
Recalling firm: Ascend Laboratories LLC
Quantity: 34296 bottles

App-derived interpretation

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

Foreign Tablet

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Presence of Foreign Tablet/Capsule

Code information

Batch No. 20122548, Exp Date: Aug. 2022

Distribution pattern

Nationwide