Status
Ongoing
Drug Enforcement D-787-2013
Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
Classification
Class II
Report Date
July 17, 2013
Termination Date
—
Product Information
- Product description
- Trimix, compounded by Olympia Pharmacy, Orlando, FL
- Product quantity
- 24
- Reason for recall
- Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
- Recall initiation reason
- —
- Initial firm notification
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Distribution pattern
- Nationwide and PR
Location & Firm
- Recalling firm
- Lowlite Investments, Inc. D/B/A Olympia Pharmacy
- Address
-
6700 Conroy Windermere Rd, Suite 140
United States - Voluntary / Mandated
- Voluntary: Firm initiated
- Status date
- —
Codes & Dates
- Recall number
- D-787-2013
- Event ID
- 65360
- Recall initiation date
- May 29, 2013
- Center classification date
- July 11, 2013
- Code info
- 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.
- More code info
- —