D-765-2013 Class II Ongoing
FDA drug recall D-765-2013 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: 6.
Recall Details
- Product Type
- Drugs
- Report Date
- Jul 17, 2013
- Initiation Date
- May 29, 2013
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 6
Product Description
Papaverine 40 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
B0021 Exp 8/31/13, B0013 Exp 8/1/13, C5122 Exp 9/22/13, C51101 Exp 8/1/13, C5508 Exp 9/8/13, and C5119 Exp 9/19/13
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-765-2013
- openFDA file date
- Oct 26, 2026
- Loaded by RegDataLab
- Oct 27, 2026