Exact FDA event identifier

Event 84750

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

Event summary

Timeline bucket: January 22, 2020
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

Minocycline Hydrochloride Extended-Release Tablets, USP, 105 mg*, 30-count bottle, Rx Only, Manufactured by: Alkem Laboratories Ltd., Mumbai - 400 013 India, Distributed by: Ascend Laboratories, LLC, Parsippany, NJ 07054, NDC 67877-438-30.

D-0827-2020

Recall number: D-0827-2020
Initiated: January 22, 2020
Classification: Class III
Status: Terminated
Recalling firm: Ascend Laboratories LLC
Quantity: 4728 bottles

App-derived interpretation

Potency or specification failure reason.potency_specification_failure · v1.0.0

out of specification

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Failed Dissolution Specifications: low out of specification results for dissolution testing.

Code information

Lot #: 19140414, Exp 12/2020

Distribution pattern

Nationwide in the USA