FDA recall D-0331-2021

Product

Lidocaine Ointment USP, 5%, NET WT 35.44 g (1 1/4 Oz) tube, Rx Only, Teligent Pharma Inc., Buena, New Jersey, 08310, NDC 52565-008-14.

Reason for recall

Failed Stability Specifications: product did not meet viscosity results.

Distribution

Nationwide in the USA

Key facts

Status

Terminated

Initiation date

2021-03-29

Report date

2021-04-21

Termination date

2024-07-03

Voluntary/Mandated

Voluntary: Firm initiated

Location

Buena, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0331-2021