FDA recall D-0785-2021

Product

Lidocaine Ointment USP, 5% Rx Only, Net Wt 35.44 g(1 1/4 oz)packaged in a laminat tube, Teligent Pharma, Inc. Buena, New Jersey 08310, NDC 52565-008-14.

Reason for recall

Failed Viscosity Specifications: lot does not meet specification for Viscosity, which was determined through routine testing.

Distribution

Distributed Nationwide in the USA

Key facts

Status

Terminated

Initiation date

2021-07-29

Report date

2021-09-08

Termination date

2024-08-15

Voluntary/Mandated

Voluntary: Firm initiated

Location

Buena, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0785-2021