FDA recall D-971-2013

Product

KETOROLAC TROMETHAMINE 60 MG/ML INJECTABLE, all presentations, FOR INTRAVENO and SQ USE ONLY, STERILE, RX ONLY, Compounded by Beacon Hill Medical Pharmacy PC, dba Rxtra Solutions, Southfield, MI

Reason for recall

Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance

Distribution

USA nationwide

Key facts

Status

Terminated

Initiation date

2013-07-26

Report date

2013-09-18

Termination date

2014-07-18

Voluntary/Mandated

Voluntary: Firm initiated

Location

Southfield, MI, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-971-2013