D-770-2013 Class II Ongoing
FDA drug recall D-770-2013 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
Phentolamine 20 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
B31012 Exp 8/31/13, B5102 Exp 8/10/13, C5228 Exp 9/22/13, B5012 Exp 12/31/13, and C5111 exp 9/11/13