FDA recall D-0714-2022

Direct Rx · Class II · drug

Product

Diclofenac Sodium Topical Solution 1.5%, 150 mL, Rx only, Packaged and Distributed by: Direct Rx Dawsonville, GA 30534 Mfg. For SOLA Pharmaceuticals Baton Rouge, LA, NDC 61919-675-05

Reason for recall

Defective Container: Leaking containers.

Distribution

Nationwide within the United States

Key facts

Status: Terminated
Initiation date: 2021-12-07
Report date: 2022-03-30
Termination date: 2023-10-05
Voluntary/Mandated: Voluntary: Firm initiated
Location: Dawsonville, GA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0714-2022