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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 85742

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

Open FDA event record

Event summary

Timeline bucket
May 19, 2020
Product types
Drug
Classifications
Class III
Statuses
Terminated
Recalling firm wording
Flexion 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

Zilretta (triamcinolone acetonide extended-release injectable suspension), 32mg per vial, 5mL vials, Single-dose Kits, Rx Only, Manufactured for: Flexion Therapeutics, Inc. 10 Mall Road, Suite 301, Burlington, MA 01803, NDC 70801-003-01

D-1376-2020
Recall number
D-1376-2020
Initiated
May 19, 2020
Classification
Class III
Status
Terminated
Quantity
792 kits

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Temperature Abuse: Product was stored at room temperature longer than 6 weeks and was inadvertently distributed instead of discarded

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Temperature Abuse: Product was stored at room temperature longer than 6 weeks and was inadvertently distributed instead of discarded

Code information

Lot #: ZA19014, exp. date 05/2021 Only the specific lot distributed by Besse Medical are affected.

Distribution pattern

Nationwide within the United States only lots distributed by Besse Medical are affected.