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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 90712

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

Open FDA event record

Event summary

Timeline bucket
August 02, 2022
Product types
Drug
Classifications
Class III
Statuses
Terminated
Recalling firm wording
HERON THERAPEUTICS, 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

Zynrelef (bupivacaine and meloxicam), 400 mg bupivacaine and 12 mg meloxicam single dose application, packaged in a kit, Rx only, Manufactured for Heron Therapeutics, Inc., San Diego, CA, NDC 47426-301-02

D-1335-2022
Recall number
D-1335-2022
Initiated
August 02, 2022
Classification
Class III
Status
Terminated
Recalling firm
HERON THERAPEUTICS, INC.
Quantity
1790 kits

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Defective Delivery System: An incorrect 10 mL (12 mL) Luer (slip) syringe packaged in one lot of Zynrelef 400 mg/12 mg kit

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Defective Delivery System: An incorrect 10 mL (12 mL) Luer (slip) syringe packaged in one lot of Zynrelef 400 mg/12 mg kit

Code information

Lot #: 01126739, Exp 7/31/2023

Distribution pattern

U.S.A. Nationwide