FDA Drug Class II — Moderate

"NB2014" 30 mg/6 mg/300 mcg/0.3 mg/mL (phentolamine mesylate, papaverine, alprostadil, atropine) injectable packaged in a clear glass injectable vial, Martin Avenue Pharmacy, 1247 Rickert Dr, Naperville, IL.

Hazard

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.

Products

"NB2014" 30 mg/6 mg/300 mcg/0.3 mg/mL (phentolamine mesylate, papaverine, alprostadil, atropine) injectable packaged in a clear glass injectable vial, Martin Avenue Pharmacy, 1247 Rickert Dr, Napervil
Brand
Martin Avenue Pharmacy, Inc.
UPC
Lot Number: 07152014@52, Exp 9/30/2014; 07202014@7, Exp 10/18/2014

Units Affected

85 mL