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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 76421

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

Open FDA event record

Event summary

Timeline bucket
February 07, 2017
Product types
Drug
Classifications
Class III
Statuses
Terminated
Recalling firm wording
Actavis 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

Levofloxacin Ophthalmic Solution, 0.5%, Sterile, packaged in 5mL bottles, Rx Only, Manufactured by Hi-Tech Pharmacal Co., Inc., Amityville, NY 11707, NDC 50383-283-05

D-0514-2017
Recall number
D-0514-2017
Initiated
February 07, 2017
Classification
Class III
Status
Terminated
Recalling firm
Actavis Inc
Quantity
14280 bottles

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Failed Impurities/ Degradation Specifications: OOS for related compound (levofloxacin n-oxide) at the 18 month stability time point.

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Failed Impurities/ Degradation Specifications: OOS for related compound (levofloxacin n-oxide) at the 18 month stability time point.

Code information

Lot # 348748, Exp 11/30/2017; 350578, Exp 3/31/2018; 633467, Exp 3/31/2017

Distribution pattern

Nationwide