FDA recall D-555-2013

Product

Dexamethasone 10 mg/mL Injectable, 2 mL vial, compounded by The Compounding Shop, St. Petersburg, FL

Reason for recall

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

Distribution

Florida, California, Minnesota, and Maine

Key facts

Status

Terminated

Initiation date

2013-05-02

Report date

2013-06-12

Termination date

2024-09-30

Voluntary/Mandated

Voluntary: Firm initiated

Location

St Petersburg, FL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-555-2013