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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 89807

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

Open FDA event record

Event summary

Timeline bucket
December 07, 2021
Product types
Drug
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Direct Rx

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

Diclofenac Sodium Topical Solution 1.5%, 150 mL, Rx only, Packaged and Distributed by: Direct Rx Dawsonville, GA 30534 Mfg. For SOLA Pharmaceuticals Baton Rouge, LA, NDC 61919-675-05

D-0714-2022
Recall number
D-0714-2022
Initiated
December 07, 2021
Classification
Class II
Status
Terminated
Recalling firm
Direct Rx
Quantity
312 bottles

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Defective Container: Leaking containers.

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Defective Container: Leaking containers.

Code information

Lot #: 24MA2010 Exp. 1/31/2023

Distribution pattern

Nationwide within the United States