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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 89016

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

Open FDA event record

Event summary

Timeline bucket
November 09, 2021
Product types
Drug
Classifications
Class II
Statuses
Terminated
Recalling firm wording
PAR Sterile Products 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

Buprenorphine HCl, Injection, 0.3mg/mL, For Intramuscular or Intravenous Use, Rx Only, 1mL Single Dose Vial, (supplied in packages of 5 vials) Distributed by Par Pharmaceutical, Chestnut Ridge, NY 10977, NDC: 42023-179-05

D-0087-2024
Recall number
D-0087-2024
Initiated
November 09, 2021
Classification
Class II
Status
Terminated
Recalling firm
PAR Sterile Products LLC
Quantity
Unavailable

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Crystallization; identified as Buprenorphine free base

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Crystallization; identified as Buprenorphine free base

Code information

Lot No: 343716, Exp. Date: 11/2021; Lot No: 350565, Exp. Date: 07/2022; Lot No: 26921, Exp. Date: 07/2022; Lot No: 36227, Exp. Date: 02/2023

Distribution pattern

Nationwide USA