D-571-2013 Class II Terminated
FDA drug recall D-571-2013 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 September 30, 2024). Affected quantity: 10 vials of 30 mL each.
Recall Details
- Product Type
- Drugs
- Report Date
- June 12, 2013
- Initiation Date
- May 2, 2013
- Termination Date
- September 30, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 10 vials of 30 mL each
Product Description
MIC (Methionine, Inositol, and Choline) Injectable, 30 mL vials, 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