D-698-2013 Class II Ongoing

Recalled by Lowlite Investments, Inc. D/B/A Olympia Pharmacy — Orlando, FL

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
1

Product Description

Aminocaproic Acid 250 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

B3727 Exp 8/7/13