D-0152-2015 Class II Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- November 5, 2014
- Initiation Date
- August 27, 2014
- Termination Date
- May 31, 2018
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 5 mL
Product Description
Tri-mix, 30 mg/3 mg/5 mcg/mL (papaverine, phentolamine mesylate, alprostadil) injectable packaged in a clear glass injectable vial, Martin Avenue Pharmacy, 1247 Rickert Dr, Naperville, IL.
Reason for Recall
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.
Distribution Pattern
Nationwide
Code Information
Lot Number: 07302014@33, Exp 10/28/2014