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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 84311

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

Open FDA event record

Event summary

Timeline bucket
November 21, 2019
Product types
Drug
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Pacira Pharmaceuticals, 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

EXPAREL, Bupivicaine Liposome Injectable Suspension, 1.3%, 266 mg/20 mL (13 mg/mL), Sterile, 20 mL vial, Rx only, Manufactured by: Pacira Pharmaceuticals, Inc. San Diego, CA 92121. NDC: 65250-266-20,

D-0621-2020
Recall number
D-0621-2020
Initiated
November 21, 2019
Classification
Class II
Status
Terminated
Quantity
910 20 mL 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 (OOS)

Code information

Pacira Lot #: 19-5002, Patheon manufacturer Lot #: 098214; Exp. Date: Dec 2019

Distribution pattern

Distributed Nationwide in the USA