Home / Recalls / Teligent Pharma, Inc. / D-0295-2022

D-0295-2022 Class I Ongoing

Recalled by Teligent Pharma, Inc. — Buena, NJ

FDA drug recall D-0295-2022 was initiated by Teligent Pharma, Inc. on Nov 30, 2021 and is designated Class I. Reason for recall: Superpotent Drug The recall status is ongoing. Affected quantity: 6,816 bottles.

Recall Details

Product Type: Drugs
Report Date: Jan 5, 2022
Initiation Date: Nov 30, 2021
Termination Date: N/A
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 6,816 bottles

Product Description

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

Reason for Recall

Superpotent Drug

Distribution Pattern

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

Code Information

Lot #: 16345, Exp. Date 01/2024

Source

Dataset: openFDA drug recall enforcement reports
FDA record: This recall in openFDA (JSON)
Enforcement Report: Search FDA's Enforcement Report for D-0295-2022
openFDA file date: Oct 6, 2026
Loaded by RegDataLab: Oct 12, 2026

These dates say when openFDA published the data file and when RegDataLab last loaded it. FDA may have changed the recall since.

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