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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 62940

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

Open FDA event record

Event summary

Timeline bucket
June 18, 2012
Product types
Drug
Classifications
Class III
Statuses
Terminated
Recalling firm wording
Stat Rx USA

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

Tobramycin Ophthalmic Oint., 0.3%, 5ml bottle, (Generic for: Tobrex), Rx only, Sterile, Mfg By Akorn, Inc., Lake Forest, IL 60045, NDC 16590-224-05,

D-050-2013
Recall number
D-050-2013
Initiated
June 18, 2012
Classification
Class III
Status
Terminated
Recalling firm
Stat Rx USA
Quantity
22 units

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
Labeling: Label Mix-up

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Labeling: Label Mix-up: The affected units were labeled incorrectly describing the product as "ointment" instead of "solution."

Code information

Lot 06JN1265 Exp 3/14 and 06JN1266 Exp 4/14

Distribution pattern

FL, PA, and VA.