D-782-2013 Class II Ongoing
FDA drug recall D-782-2013 was initiated by Lowlite Investments, Inc. D/B/A Olympia Pharmacy on May 29, 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 ongoing. Affected quantity: 10.
Recall Details
- Product Type
- Drugs
- Report Date
- Jul 17, 2013
- Initiation Date
- May 29, 2013
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 10
Product Description
Sodium Tetradecyl Sulfate (0.125%, 1%, 2.5%, 3%, and 4%) 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
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
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-782-2013
- openFDA file date
- Oct 26, 2026
- Loaded by RegDataLab
- Oct 27, 2026