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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 94568

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

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Event summary

Timeline bucket
May 07, 2024
Product types
Drug
Classifications
Class II
Statuses
Ongoing
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

Drug Vial Label: Zilretta¿ (triamcinolone acetonide extended-release injectable suspension), 32 mg per vial, Rx only, Manufactured for: Pacira Pharmaceuticals Inc., San Diego, CA 92121, NDC 65250-001-01. Diluent Vial Label: Diluent, 5mL, Sterile single use, Rx only, Manufactured for Pacira Pharmaceuticals Inc., NDC 65250-002-01. Carton Label: Drug Vial Label: Zilretta¿ (triamcinolone acetonide extended-release injectable suspension), 32 mg per vial, Rx only, Manufactured for: Pacira Pharmaceuticals Inc., San Diego, CA 92121, NDC 65250-003-01.

D-0546-2024
Recall number
D-0546-2024
Initiated
May 07, 2024
Classification
Class II
Status
Ongoing
Quantity
43,768 kits

App-derived interpretation

Potency or specification failure reason.potency_specification_failure · v1.0.0
Failed Stability Specifications

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Failed Stability Specifications - at 12 months 2-8 degrees C followed by 6 weeks at 25 degrees C.

Code information

Lot: 082657 (kit 23-9004), Exp: July 2024.

Distribution pattern

U.S. Nationwide.

Field note

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