FDA recall D-0161-2015

Product

Tri-mix T101, 17.65 mg/0.59 mg/5.9 mcg/mL (papaverine, phentolamine mesylate, alprostadil) injectable packaged in a clear glass injectable vial, Martin Avenue Pharmacy, 1247 Rickert Dr, Naperville, IL.

Reason for recall

Lack of Assurance of Sterility: Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of all compounded sterile preparations within expiry. The recall is being initiated in connection with a recent FDA inspection due to observations associated with certain quality control procedures that present a risk to sterility assurance.

Distribution

Nationwide

Key facts

Status

Terminated

Initiation date

2014-08-27

Report date

2014-11-05

Termination date

2018-05-31

Voluntary/Mandated

Voluntary: Firm initiated

Location

Naperville, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0161-2015