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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 83093

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

Open FDA event record

Event summary

Timeline bucket
June 17, 2019
Product types
Drug
Classifications
Class III
Statuses
Terminated
Recalling firm wording
Bausch & Lomb

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

Lotemax (loteprednol etabonate ophthalmic gel 0.5%), Sterile, Rx Only, 5 g box, Bausch & Lomb, a division of Valeant Pharmaceuticals North America LLC Bridgewater, NJ 08807 USA, NDC 24208-503-07.

D-1396-2019
Recall number
D-1396-2019
Initiated
June 17, 2019
Classification
Class III
Status
Terminated
Recalling firm
Bausch & Lomb
Quantity
170832 bottles

App-derived interpretation

Potency or specification failure reason.potency_specification_failure · v1.0.0
Out of specification

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Failed Stability Specifications: Out of specification for viscosity.

Code information

Lot #s: 282611; 283431; 283441; 283451, Exp. 10/2019; 282971; 282981; 283611; 283621; 283631, Exp. 11/2019.

Distribution pattern

Nationwide in the U.S.