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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 88850

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

Open FDA event record

Event summary

Timeline bucket
October 12, 2021
Product types
Drug
Classifications
Class I and 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

3 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 3

Lidocaine Hydrochloride Topical Solution USP 4% (40 mg/mL), 50 mL glass bottles, Rx Only, Manufactured by: Teligent Pharma Inc., Buena, NJ 06310, Distributed by: McKesson Corporation dba Sky Packaging, 497 Southridge Blvd, Suite 101, Memphis, TN 36141, NDC 63739-997-64.

D-0279-2022
Recall number
D-0279-2022
Initiated
October 12, 2021
Classification
Class II
Status
Terminated
Recalling firm
Teligent Pharma, Inc.
Quantity
7,008 glass bottles

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
CGMP Deviations
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

CGMP Deviations: Lots recalled because they were manufactured at the same facility using the same components as the products that had cracked seals in caps that were found to be superpotent.

Code information

Lot #: 16306, Exp. Date 01/2024.

Distribution pattern

Nationwide within the United States

drug · product 2 of 3

Lidocaine Hydrochloride Topical Solution USP 4% (40 mg/mL), 50 mL glass bottles, Rx Only, Teligent Pharma Inc., Buena, NJ 08310, NDC 52565-009-50

D-0280-2022
Recall number
D-0280-2022
Initiated
October 12, 2021
Classification
Class I
Status
Terminated
Recalling firm
Teligent Pharma, Inc.
Quantity
52,104 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 #: 13262, Exp. 03/2022; 14217, Exp. 08/2022

Distribution pattern

Nationwide within the United States

drug · product 3 of 3

Lidocaine Hydrochloride Topical Solution USP 4% (40 mg/mL), 50 mL glass bottles, Rx Only, Teligent Pharma Inc., Buena, NJ 08310, NDC 52565-009-50

D-0281-2022
Recall number
D-0281-2022
Initiated
October 12, 2021
Classification
Class II
Status
Terminated
Recalling firm
Teligent Pharma, Inc.
Quantity
14,664 glass bottles

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
CGMP Deviations
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

CGMP Deviations: Lots recalled because they were manufactured at the same facility using the same components as the products that had cracked seals in caps that were found to be superpotent.

Code information

Lot #: 13058, Exp. date 02/2022 and 13768, Exp. date 05/2022

Distribution pattern

Nationwide within the United States