Exact FDA event identifier

Event 87950

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

Event summary

Timeline bucket: May 14, 2021
Product types: Drug
Classifications: Class II
Statuses: Terminated
Recalling firm wording: Teligent Pharma, 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

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

Diflorasone Diacetate Ointment USP, 0.05%, packaged in a)15 g (NDC 52565-063-15) and b) 30 g (NDC 52565-063-30) tubes, Rx only, Manufactured by: Teligent Pharma, Inc, Buena, NJ 08310.

D-0636-2021

Recall number: D-0636-2021
Initiated: May 14, 2021
Classification: Class II
Status: Terminated
Recalling firm: Teligent Pharma, Inc.
Quantity: 6,240 tubes

App-derived interpretation

Foreign material or chemical contamination reason.foreign_material_chemical_contamination · v1.0.0

Foreign Substance

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Presence of Foreign Substance: Foreign particles observed during routine stability testing.

Code information

Lot #: 16264, Exp Date Nov 2022

Distribution pattern

Nationwide in the United States