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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 82223

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

Open FDA event record

Event summary

Timeline bucket
February 22, 2019
Product types
Drug
Classifications
Class II
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

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

Tamsulosin Hydrochloride Capsules, USP, 0.4 mg, 500-count bottles, Rx Only, Manufactured by: Alkem Laboratories Ltd., Mumbai - 400 013, INDIA; Distributed by Ascend Laboratories, LLC, Parsippany, NJ 07054, NDC 67877-450-05.

D-1066-2019
Recall number
D-1066-2019
Initiated
February 22, 2019
Classification
Class II
Status
Terminated
Recalling firm
Ascend Laboratories LLC
Quantity
3,072 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: High Out-of-Specification dissolution results were observed during stability testing.

Code information

Lot #: 8144652, Exp Jul 2020

Distribution pattern

Nationwide in the USA and Puerto Rico.