D-0057-2015 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
- 800 mL
Product Description
Alprostadil alcohol 500 mcg/mL injectable packaged in amber 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: 05022014@19, Exp 10/29/2014; 05022014@28, Exp 10/29/2014; 06122014@17, Exp 12/9/2014; 07302014@22, Exp 1/26/2015