FDA recall D-782-2013

Lowlite Investments, Inc. D/B/A Olympia Pharmacy · Class II · drug

Product

Sodium Tetradecyl Sulfate (0.125%, 1%, 2.5%, 3%, and 4%) Injection, compounded by Olympia Pharmacy, Orlando, FL

Reason for recall

Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes

Distribution

Nationwide and PR

Key facts

Status
Ongoing
Initiation date
2013-05-29
Report date
2013-07-17
Voluntary/Mandated
Voluntary: Firm initiated
Location
Orlando, FL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-782-2013