FDA recall D-0004-2017

Product

Tri-Mix 18/1/10 (Papaverine 18mg, Phentolamine 1 mg, Prostaglandin 10 mcg/mL) packaged in 2.5 mL sterile vials, IM, Rx, The Apothecary Shoppe, Jenks, OK

Reason for recall

Lack of Assurance of Sterility; medication was sterilized with a recalled filter

Distribution

Oklahoma

Key facts

Status

Terminated

Initiation date

2016-09-12

Report date

2016-10-12

Termination date

2018-01-25

Voluntary/Mandated

Voluntary: Firm initiated

Location

Tulsa, OK, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0004-2017