# FDA recall D-0279-2022

> **Teligent Pharma, Inc.** · Class II · drug recall initiated 2021-10-12.

## Product

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.

## 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.

## Distribution

Nationwide within the United States

## Key facts

- **Recall number:** D-0279-2022
- **Recalling firm:** Teligent Pharma, Inc.
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2021-10-12
- **Report date:** 2021-12-22
- **Termination date:** 2024-06-18

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Buena, NJ, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0279-2022

## Citation

> AI Analytics. FDA recall D-0279-2022. Retrieved 2026-06-09 from https://api.ai-analytics.org/recall/D-0279-2022. Source: US FDA. Licensed CC0.

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