FDAFDA · Food and drugs·Recall number D-0107-2015
"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.
Published November 5, 2014 · Recall initiated: August 27, 2014
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the 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.
What to do
Voluntary: Firm initiated · Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Recall details
- Manufacturer
- Martin Avenue Pharmacy, Inc.
- Distributor
- Nationwide
- Lot
- Lot Number: 07152014@52, Exp 9/30/2014; 07202014@7, Exp 10/18/2014
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
Sell products like this?
Recalert watches your whole catalog for recalls like this one, automatically.