Exact FDA event identifier

Event 88454

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

Event summary

Timeline bucket: August 03, 2021
Product types: Drug
Classifications: Class I
Statuses: Ongoing
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 Hydrochloride Topical Solution, USP, 4% , 50 mL glass bottles, Rx Only, Teligent Pharma Inc. Buena, New Jersey 08310, NDC 52565-009-50.

D-0800-2021

Recall number: D-0800-2021
Initiated: August 03, 2021
Classification: Class I
Status: Ongoing
Recalling firm: Teligent Pharma, Inc.
Quantity: 32,544 glass bottles

App-derived interpretation

Potency or specification failure reason.potency_specification_failure · v1.0.0

Superpotent

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Superpotent Drug

Code information

Lot #:14218, Exp. Date 08/2022

Distribution pattern

Nationwide within the United States and Canada