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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 86243

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

Open FDA event record

Event summary

Timeline bucket
August 14, 2020
Product types
Drug
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Hikma Pharmaceuticals USA Inc.

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

Buprenorphine HCl Injection, 0.3 mg/mL, 1 mL vial, For Intramuscular or Intravenous Use Only, Rx Only, Manufactured by: Hikma Farmaceutica, Portugal S.A., Distributed by: Hikma Pharmaceuticals, Eatontown, NJ 07724, USA Inc., NDC: 0143-9246-01.

D-1533-2020
Recall number
D-1533-2020
Initiated
August 14, 2020
Classification
Class II
Status
Terminated
Quantity
97,890 vials

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

Sub-potent Drug: Out-of-Specification assay results found at 3 month stability testing.

Code information

Lot #s: 2005023.1, 2005024.1, 2005025.1, Exp 02/28/2021

Distribution pattern

Nationwide in the U.S.