FDA recall D-0281-2022

Product

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

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

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

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0281-2022