FDA recall D0384-2015

Product

Compounded Plaquex, intravenous injection, 50 ML vial. Each ml contains: Phosphatidyl Choline 50 mg, Sodium Deoxycholate 25 mg, Benzyl Alcohol 0.9%, Ethanol (95%) 2.4 mg di Alpha Tocopheryl Acetate 0.2 mg in Sterile Water for injection.

Reason for recall

Good Manufacturing Practices Deviations: The product has an active pharmaceutical ingredient from an unapproved source.

Distribution

Nationwide

Key facts

Status

Terminated

Initiation date

2015-01-26

Report date

2015-02-18

Termination date

2015-02-09

Voluntary/Mandated

Voluntary: Firm initiated

Location

Las Vegas, NV, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D0384-2015