D-778-2013 Class II Ongoing
FDA drug recall D-778-2013 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: 3.
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
- 3
Product Description
Quadmix, 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
C4526 Exp 9/4/13, B4125 exp 8/12/13, and B5014 exp 8/1/13