FDA recall D-0258-2022

Teligent Pharma, Inc. · Class II · drug

Product

Diclofenac Sodium Topical Solution USP, 1.5 w/w, 5 fl oz (150 mL) plastic bottles, Rx only, Teligent Pharma, Inc., Buena, New Jersey, 08310, NDC 52565-002-05

Reason for recall

Defective Container

Distribution

Nationwide within the United States

Key facts

Status
Terminated
Initiation date
2021-10-19
Report date
2021-12-01
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-0258-2022