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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 88145

2 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
June 22, 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

Complete imported group

Every recalled product in this event

2 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 2

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

D-0689-2021
Recall number
D-0689-2021
Initiated
June 22, 2021
Classification
Class III
Status
Terminated
Recalling firm
Teligent Pharma, Inc.
Quantity
7872 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

Code information

Lot 14180

Distribution pattern

Nationwide

drug · product 2 of 2

Erythromycin Topical Gel, 2%, Net Wt. (a) 30 g,(NDC 52565-033-30) (b) 60 g,(NDC 52565-033-60) Rx Only, Manufactured by: Teligent Pharma, Inc. , Buena, NJ 08310,

D-0690-2021
Recall number
D-0690-2021
Initiated
June 22, 2021
Classification
Class III
Status
Terminated
Recalling firm
Teligent Pharma, Inc.
Quantity
22,824 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

Code information

1) NDC 52565-033-30 Lot 14010, Exp July 2021; 2) NDC 52565-033-60 Lot 13865, Exp June 2021; Lot 14011, Exp July 2021.

Distribution pattern

Nationwide