D-1009-2017 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 (as citrate) 10 mcg per mL in 0.9% Sodium Chloride 250 mL Bag, Rx only, SCA Pharmaceuticals 8821 Knoedl Ct Little Rock, AR 72205 --- NDC# 70004-0202-40
Reason for Recall
Lack of Assurance of Sterility; product has the potential to leak.
Distribution Pattern
Nationwide
Code Information
Lots: 20170502@18 BUD: 7/31/2017; 20170502@39 BUD: 7/31/2017; 20170502@62 BUD: 7/31/2017; 20170503@22 BUD: 8/1/2017; 20170503@4 BUD: 8/1/2017; 20170503@54 BUD: 8/1/2017; 20170504@10 BUD: 8/2/2017; 20170505@15 BUD: 8/3/2017; 20170506@23 BUD: 8/4/2017