D-768-2013 Class II Ongoing
Recall Details
- Product Type
- Drugs
- Report Date
- July 17, 2013
- Initiation Date
- May 29, 2013
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 3
Product Description
Pentosan 250 mg/ml Injection, compounded by Olympia Pharmacy, Orlando, FL
Reason for Recall
Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
Distribution Pattern
Nationwide and PR
Code Information
K5629 Exp 11/30/13, C51013 Exp 9/10/13 and C5513 Exp 9/14/13