FDA recall D-0694-2022

Teligent Pharma, Inc. · Class II · drug

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

cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program.

Distribution

Nationwide in the USA and Puerto Rico

Key facts

Status
Terminated
Initiation date
2022-03-15
Report date
2022-03-30
Termination date
2024-06-17
Voluntary/Mandated
Voluntary: Firm initiated
Location
Buena, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0694-2022