D-0062-2015 Class II Terminated
FDA drug recall D-0062-2015 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: 600 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
- 600 mL
Product Description
Bacteriostatic water for injection packaged in an 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: 03082014@2, Exp 9/4/2014; 04142014@8, Exp 10/11/2014; 05242014@2, Exp 11/20/2014; 06202014@20, Exp 12/17/2014; 08192014@33, Exp 2/15/2015
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0062-2015
- openFDA file date
- Oct 27, 2026
- Loaded by RegDataLab
- Oct 29, 2026