Exact FDA event identifier

Event 87631

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

Event summary

Timeline bucket: March 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%, NET WT 35.44 g (1 1/4 Oz) tube, Rx Only, Teligent Pharma Inc., Buena, New Jersey, 08310, NDC 52565-008-14.

D-0331-2021

Recall number: D-0331-2021
Initiated: March 29, 2021
Classification: Class III
Status: Terminated
Recalling firm: Teligent Pharma, Inc.
Quantity: 62,040 tubes

App-derived interpretation

Potency or specification failure reason.potency_specification_failure · v1.0.0

Failed Stability Specifications

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Failed Stability Specifications: product did not meet viscosity results.

Code information

Lot 13269, Exp March 2021

Distribution pattern

Nationwide in the USA