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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 89560

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

Open FDA event record

Event summary

Timeline bucket
February 07, 2022
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

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 Gel USP, 2%, Net Wt 30 g tube, Rx only, Manufactured by: Teligent Pharma, Inc., Buena, NJ 08310, Distributed by: McKesson Corporation, dba Sky Packaging, 4971 Southridge Blvd., Suite 101, Memphis, TN 38141, NDC 63739-053-66.

D-0716-2022
Recall number
D-0716-2022
Initiated
February 07, 2022
Classification
Class II
Status
Terminated
Recalling firm
Teligent Pharma, Inc.
Quantity
11040 tubes

App-derived interpretation

Potency or specification failure reason.potency_specification_failure · v1.0.0
Failed Impurities/Degradation Specifications

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Failed Impurities/Degradation Specifications: Lot not meeting specification for Unknown Max Related Compounds.

Code information

Lot: 15724, Exp. 06/2022

Distribution pattern

Nationwide in the USA.