FDA recall D-0252-2015

Product

Trace Mineral-5 MDV, supplied in 10 mL vials, Each ML contains: 1 mg Zinc (as sulfate), 0.4 mg Copper (as sulfate), 0.1 mg Manganese (as sulfate), 4 mcg Chromium (as chloride), 20 mcg Selenium (as sodium), 0.9% Benzyl alcohol in water for injection, Rx Only, Compounded Medication, ABRAMS ROYAL Compounding Pharmacy, Dallas, TX

Reason for recall

Non-Sterility; contract laboratory identified Staphylococcus warneri in the product

Distribution

Nationwide

Key facts

Status

Terminated

Initiation date

2013-05-13

Report date

2014-11-26

Termination date

2016-10-07

Voluntary/Mandated

Voluntary: Firm initiated

Location

Dallas, TX, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0252-2015