Exact FDA event identifier

Event 91768

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

Open FDA event record

Event summary

Timeline bucket: February 24, 2023
Product types: Drug
Classifications: Class I
Statuses: Ongoing
Recalling firm wording: Global Pharma Healthcare Private Limited

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

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

Delsam Pharma's Artificial Eye Ointment (Mineral Oil 15%, White Petrolatum 83%), 3.5 grams (1/8 oz.) tube, Distributed By: Delsam Pharma Lic, Bronx, Newyork 10469, NDC 72570 122 35, UPC 3 72570 12235 3.

D-0488-2023

Recall number: D-0488-2023
Initiated: February 24, 2023
Classification: Class I
Status: Ongoing
Recalling firm: Global Pharma Healthcare Private Limited
Quantity: 50,000 tubes

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Non-Sterility: FDA analysis found unopened tubes to be contaminated with bacteria.

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Non-Sterility: FDA analysis found unopened tubes to be contaminated with bacteria.

Code information

Batch # H29, Exp. Date 11/30/2023

Distribution pattern

Product was imported by one distributor, Delsam Pharma, LLC, who further distributed the product via internet sales Nationwide in the USA.