Skip to content
Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 64198

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

Open FDA event record

Event summary

Timeline bucket
December 17, 2012
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 (bupivacaine liposome injectable suspension), 1.3%, 266 mg/20 mL (13.3 mg/mL) single use vials, INVESTIGATIONAL USE. For Infiltration Only. Not for any other route of administration. Manufactured by Paelra Pharmaceuticals. Inc., San Diego, California, USA

D-168-2013
Recall number
D-168-2013
Initiated
December 17, 2012
Classification
Class II
Status
Terminated
Quantity
324 vials

App-derived interpretation

Potency or specification failure reason.potency_specification_failure · v1.0.0
Subpotent

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Subpotent; bupivacaine

Code information

Lot #11-2005 Control #23542 Manufacture Date: 05Dec11 2011-L-009

Distribution pattern

Nationwide distribution: AZ, DC, FL, GA, MA, NJ, NY, OH, and TX.