D-0149-2015 Class II Terminated
FDA drug recall D-0149-2015 was initiated by Martin Avenue Pharmacy, Inc. on Aug 27, 2014 and is designated Class II. 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… The recall status is terminated (terminated May 31, 2018). Affected quantity: 75 mL.
Recall Details
- Product Type
- Drugs
- Report Date
- Nov 5, 2014
- Initiation Date
- Aug 27, 2014
- Termination Date
- May 31, 2018
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 75 mL
Product Description
Tri-mix, 30 mg/1 mg/20 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: 07142014@39, Exp 9/30/2014; 07262014@1, Exp 10/24/2014
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0149-2015
- openFDA file date
- Oct 27, 2026
- Loaded by RegDataLab
- Oct 29, 2026