D-1013-2017 Class II Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- August 2, 2017
- Initiation Date
- July 14, 2017
- Termination Date
- May 1, 2019
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- N/A
Product Description
fentaNYL 10 mcg/mL PF in Sodium Chloride 250 mL (Total Dose=2500 mcg), Rx only, SCA Pharmaceuticals 8821 Knoedl Ct Little Rock, AR 72205 --- NDC# 70004-0229-40
Reason for Recall
Lack of Assurance of Sterility; product has the potential to leak.
Distribution Pattern
Nationwide
Code Information
Lots: 20170509@20 BUD: 8/7/2017; 20170509@21 BUD: 8/7/2017; 20170509@46 BUD: 8/7/2017; 20170511@33 BUD: 8/9/2017