D-787-2013 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
- 24
Product Description
Trimix, 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
B5015 Exp 8/15/13, C50001 Exp 8/28/13, B5011 Exp 8/1/13, C42215 Exp 6/22/13, A5028 Exp 6/2/13, B5011 Exp 6/1/13, B5020 Exp 6/1/13, B50112 Exp 8/11/13, C4186 Exp 6/18/13, C4158 Exp 6/15/13, C4149 Exp 6/14/13, C4111 Exp 6/11/13, B4124 Exp 8/12/13, B4154 Exp 8/15/13, B4198 Exp 8/19/13, B4226 Exp 8/22/13, B4268 Exp 8/22/13, C40522 Exp 9/5/13, C4118 Exp 9/1/13, C4711 Exp 9/7/13, C41121 Exp 9/11/13, C4126 Exp 9/12/13 and B42715 Exp 8/27/13.