D-695-2013 Class II Ongoing
FDA drug recall D-695-2013 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: 5.
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
- 5
Product Description
Alprostadil 2000 mcg/ml, 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
B5008 exp 12/31/13, K5030 Exp. 11/30/13, A5716 Exp. 8/31/13, C5121 Exp 9/12/13, and C5208 Exp 9/7/13