drugs Class II Updated 2014-11-05

Martin Avenue Pharmacy, Inc. recalls Tri-mix, 30 mg/2 mg/10 mcg/mL (papaverine, phentolamine mesy

Recalled Product

Tri-mix, 30 mg/2 mg/10 mcg/mL (papaverine, phentolamine mesylate, alprostadil) injectable packaged in a clear glass injectable vial with silver crimp top and sold under the Martin Avenue Pharmacy brand.

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: 08182014@23, Exp 11/16/2014
View official government recall

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