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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 89135

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

Open FDA event record

Event summary

Timeline bucket
November 30, 2021
Product types
Drug
Classifications
Class I and 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

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

Lidocaine Hydrochloride, Topical Solution USP, 4% (40 mg/mL), packaged in 50 mL screw cap bottles, 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 63739-997-64

D-0295-2022
Recall number
D-0295-2022
Initiated
November 30, 2021
Classification
Class I
Status
Ongoing
Recalling firm
Teligent Pharma, Inc.
Quantity
6,816 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 #: 16345, Exp. Date 01/2024

Distribution pattern

Distributed to a wholesaler in CO who further distributed Nationwide in the USA

drug · product 2 of 2

Lidocaine Hydrochloride, Topical Solution USP, 4% (40 mg/mL), packaged in 50 mL screw cap bottles, 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 63739-997-64

D-0296-2022
Recall number
D-0296-2022
Initiated
November 30, 2021
Classification
Class II
Status
Ongoing
Recalling firm
Teligent Pharma, Inc.
Quantity
7,176 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: Minimally superpotent

Code information

Lot #: 15594, Exp Date 05/2023

Distribution pattern

Distributed to a wholesaler in CO who further distributed Nationwide in the USA