D-1001-2017 Class II Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- August 2, 2017
- Initiation Date
- July 14, 2017
- Termination Date
- October 30, 2019
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 108 bags
Product Description
ceFAZolin 3 g added to 100 mL 0.9% Sodium Chloride, Total Approximate Volume 115 mL Single Dose Container bag, Rx Only, SCA Pharmaceuticals, 8821 Knoedl Ct, Little Rock, AR 72205 (877) 550-5059; NDC: 70004-0524-32.
Reason for Recall
Lack of Assurance of Sterility: Product made with recalled 0.9% sodium chloride bags which have the potential to leak.
Distribution Pattern
Nationwide in the USA
Code Information
Lot: 20170707@26, BUD: 8/21/2017