Exact FDA event identifier

Event 88382

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

Event summary

Timeline bucket: July 29, 2021
Product types: Drug
Classifications: Class III
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

Lidocaine Ointment USP, 5% Rx Only, Net Wt 35.44 g(1 1/4 oz)packaged in a laminat tube, Teligent Pharma, Inc. Buena, New Jersey 08310, NDC 52565-008-14.

D-0785-2021

Recall number: D-0785-2021
Initiated: July 29, 2021
Classification: Class III
Status: Terminated
Recalling firm: Teligent Pharma, Inc.
Quantity: 114,456 tubes

App-derived interpretation

Potency or specification failure reason.potency_specification_failure · v1.0.0

does not meet specification

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Failed Viscosity Specifications: lot does not meet specification for Viscosity, which was determined through routine testing.

Code information

Lot #: 15378, Exp 3/2023; 14418 EXP 10/2021

Distribution pattern

Distributed Nationwide in the USA