drugs Class II Updated 2014-11-05

Martin Avenue Pharmacy, Inc. recalls Tri-mix SEST 4, 30 mg/1.5 mg/400 mcg/mL (papaverine, phentol

Recalled Product

Tri-mix SEST 4, 30 mg/1.5 mg/400 mcg/mL (papaverine, phentolamine mesylate, alprostadil) injectable packaged in a clear glass injectable vial, Martin Avenue Pharmacy, 1247 Rickert Dr, Naperville, IL.

Hazard / Issue

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.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: Lot Number: 07202014@5, Exp 9/15/2014; 07152014@1, Exp 9/30/2014
View official government recall

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