Martin Avenue Pharmacy, Inc. recalls Quad mix 2, 12 mg/1 mg/25 mcg/0.25 mg/mL (papaverine, phentolamine mesylate, alprostadil, atropine) injectable packaged
Recalled November 5, 2014 · FDA recall D-0127-2015 · Martin Avenue Pharmacy
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. · FDA Class II
Units
50 mL
Sold at
Nationwide
Description
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.
Product
Quad mix 2, 12 mg/1 mg/25 mcg/0.25 mg/mL (papaverine, phentolamine mesylate, alprostadil, atropine) injectable packaged in a clear glass injectable vial, Martin Avenue Pharmacy, 1247 Rickert Dr, Naperville, IL.
Manufacturer(s)
Martin Avenue Pharmacy, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →