Recall events
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Event 96032
Event summary
Timeline bucket December 18, 2024
Product types Drug
Classifications Class III
Statuses Ongoing
Recalling firm wording AvKARE
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
Device root-cause evidence is not applicable to this event.
No grouped product has the official product type device; this is not an unavailable-enrichment finding.
Complete imported group
Every recalled product in this event
2 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 2
Carboxymethylcellulose Sodium Ophthalmic Solution 0.5% Moisturizing Lubricant Eye Drops, 0.5 FL OZ (15 mL) bottles, Distributed by: AvKARE, Pulaski, TN, 38478, NDC 50268-068-15.
D-0175-2025
Recall number D-0175-2025
Initiated December 18, 2024
Classification Class III
Status Ongoing
Quantity 16,677 cartons
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
Code information Lot #: 0160, Exp. Date April 26 2026
Distribution pattern Nationwide within the United States
Official fact provenance
Dataset openFDA Drug Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 b791303a96cde04f35218bb062dc99bbd2aaedb7873ee857564b5dbe373c2651
Raw source locator 0001-drug-enforcement-0001-of-0001.json.zip#results[16218]
FDA event record
· Exact recall-number query on openFDA
drug · product 2 of 2
Polyvinyl Alcohol Ophthalmic Solution 1.4%, Moisturizing Lubricant Eye Drops, 0.5 FL OZ (15 mL) bottles, Distributed by AvKARE, Pulaski, TN 38478, www.avkare.com, NDC 50268-678-15
D-0176-2025
Recall number D-0176-2025
Initiated December 18, 2024
Classification Class III
Status Ongoing
Quantity 0
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
Code information Lot #: 0160, Exp. Date April 26 2026
Distribution pattern Nationwide within the United States
Official fact provenance
Dataset openFDA Drug Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 b791303a96cde04f35218bb062dc99bbd2aaedb7873ee857564b5dbe373c2651
Raw source locator 0001-drug-enforcement-0001-of-0001.json.zip#results[17784]
FDA event record
· Exact recall-number query on openFDA
