FDA recall D-0278-2022

Product

Diclofenac Sodium Topical Solution, 1.5% w/w, packaged in 150 mL bottles, Rx only, Mfg: SOLA Pharmaceuticals Preferred Pharmaceuticals, Inc., NDC 68788-7707-01

Reason for recall

Defective container: Out of specification for container integrity leading to bottles leaking.

Distribution

Distributed to 5 physician consignees located in the following states: CT, FL, and KS.

Key facts

Status

Ongoing

Initiation date

2021-11-29

Report date

2021-12-22

Voluntary/Mandated

Voluntary: Firm initiated

Location

Anaheim, CA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0278-2022