Exact FDA event identifier

Event 88377

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 II
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

Erythromycin Topical Solution USP, 2%, 60mL bottle, Rx only, Teligent Pharma, Inc. Buena, NJ 08310, NDC 52565-027-59

D-0769-2021

Recall number: D-0769-2021
Initiated: July 29, 2021
Classification: Class II
Status: Ongoing
Recalling firm: Teligent Pharma, Inc.
Quantity: 7488 bottles

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Defective container: possibility for lack of seal integrity.

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Defective container: possibility for lack of seal integrity.

Code information

Lot #: 14892, Exp 1/2022

Distribution pattern

USA Nationwide