D-557-2013 Class II Terminated
FDA drug recall D-557-2013 was initiated by THE COMPOUNDING SHOP, INC. on May 2, 2013 and is designated Class II. Reason for recall: Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes The recall status is terminated (terminated Sep 30, 2024). Affected quantity: 43 vials of 250mL each.
Recall Details
- Product Type
- Drugs
- Report Date
- Jun 12, 2013
- Initiation Date
- May 2, 2013
- Termination Date
- Sep 30, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 43 vials of 250mL each
Product Description
Sodium EDTA 150 mg/mL Injectable, 250 mL vial, compounded by The Compounding Shop, St. Petersburg, FL
Reason for Recall
Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
Distribution Pattern
Florida, California, Minnesota, and Maine
Code Information
All Lots
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-557-2013
- openFDA file date
- Oct 26, 2026
- Loaded by RegDataLab
- Oct 27, 2026