Tri-mix ST9-B, 30 mg/2 mg/100 mcg/mL (papaverine, phentolamine mesylate, alprostadil) injectable packaged in a clear glass injectable vial, Martin Avenue Pharmacy, 1247 Rickert Dr, Naperville, IL.

Recall Number: D-0159-2015

Firm: Martin Avenue Pharmacy, Inc.

Classification: Class II

Status: Terminated

Report Date: 20141105

Initiation Date: 20140827

Termination Date: 20180531

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.

Tri-mix ST9-B, 30 mg/2 mg/100 mcg/mL (papaverine, phentolamine mesylate, alprostadil) injectable packaged in a clear glass injectable vial, Martin Avenue Pharmacy, 1247 Rickert Dr, Naperville, IL.