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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 93339

2 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
October 31, 2023
Product types
Drug
Classifications
Class I
Statuses
Terminated
Recalling firm wording
The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories

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

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

Polyvinyl Alcohol 1.4% Lubricating Eye Drops, packaged in 0.5 FL OZ (15mL) bottles, Dist. by: RUGBY LABORATORIES, Livonia, MI 48152, NDC 0536-1325-94.

D-0107-2024
Recall number
D-0107-2024
Initiated
October 31, 2023
Classification
Class I
Status
Terminated
Quantity
1,271,810 bottles

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Non-Sterility: FDA found insanitary conditions and positive bacterial test results from environmental sampling at the manufacturing facility.

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Non-Sterility: FDA found insanitary conditions and positive bacterial test results from environmental sampling at the manufacturing facility.

Code information

All lots

Distribution pattern

Nationwide within the United States

drug · product 2 of 2

Lubricating Tears Eye Drops (Dextran/Hypromellose), 0.1%/0.3%, packaged in 0.5 FL OZ (15mL) bottles, Distributed by: RUGBY LABORATORIES, Livonia, MI 48152, NDC 0536-1282-94

D-0108-2024
Recall number
D-0108-2024
Initiated
October 31, 2023
Classification
Class I
Status
Terminated
Quantity
65,880 bottles

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Non-Sterility: FDA found insanitary conditions and positive bacterial test results from environmental sampling at the manufacturing facility.

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Non-Sterility: FDA found insanitary conditions and positive bacterial test results from environmental sampling at the manufacturing facility.

Code information

All lots

Distribution pattern

Nationwide within the United States