FDA recall D-1563-2014

Abrams Royal Pharamacy · Class I · drug

Product

MINERAL IV Injection, compounded by Abrams Royal Pharmacy, Inc., Dallas, TX

Reason for recall

Non-Sterility; analytical results found product to contain Sphingomonas paucimobilis

Distribution

Nationwide and to Canada

Key facts

Status
Terminated
Initiation date
2013-12-19
Report date
2014-09-03
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-1563-2014