Drug product
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
D-0876-2017
Product summary
- Event
- Event 77314
- Status
- Terminated
- Classification
- Class II
- Quantity
- 240 bags
- Official record key
drug-enforcement:D-0876-2017
Official wording
Reason: Lack of assurance of sterility: Product bags leaking at seam.
Code information: LOT # 20170510@12, Use By: 06-24-17
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Sterility assurance
Lack of assurance of sterility