Status
Ongoing
Drug Enforcement D-782-2013
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
- Sodium Tetradecyl Sulfate (0.125%, 1%, 2.5%, 3%, and 4%) Injection, compounded by Olympia Pharmacy, Orlando, FL
- Product quantity
- 10
- 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-782-2013
- Event ID
- 65360
- Recall initiation date
- May 29, 2013
- Center classification date
- July 11, 2013
- Code info
- 0.125% Lot B3505 Exp 8/1/13 // 1% Lots C5001 Exp 9/30/13, C5406 Exp 9/4/13, and C5306 Exp 9/30/13 // 2.5% Lot C5101 Exp 9/30/13 // 3% Lots B5120 Exp 10/31/13, C5301 Exp 9/30/13, B5428 Exp 6/4/13, and C5212 Exp 9/21/13 // 4% Lot C5301 Exp 9/30/13
- More code info
- —