D-0876-2017 Class II Terminated
FDA drug recall D-0876-2017 was initiated by SCA Pharmaceuticals on May 18, 2017 and is designated Class II. Reason for recall: Lack of assurance of sterility: Product bags leaking at seam. The recall status is terminated (terminated March 29, 2018). Affected quantity: 240 bags.
Recall Details
- Product Type
- Drugs
- Report Date
- June 7, 2017
- Initiation Date
- May 18, 2017
- Termination Date
- March 29, 2018
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 240 bags
Product Description
ceFAZolin sodium added to 100 mL 0.9% Sodium Chloride injectable, 2g, Total Approximate Volume 100 mL, Single Dose Container bag, Preservative Free, Rx Only, SCA Pharmaceuticals, 8821 Knoedl Ct. Little Rock, AR 72205, NDC 70004-0522-32
Reason for Recall
Lack of assurance of sterility: Product bags leaking at seam.
Distribution Pattern
Nationwide in the USA
Code Information
LOT # 20170510@12, Use By: 06-24-17