Drug product
del Nido Cardioplegia Solution 1000 mL (1000 mL) Single-Dose Container IV bag, 4 x 1 IV Bag per case, Rx Only, Nephron 503B outsourcing facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC: 69374-984-10
D-1269-2022
Product summary
- Event
- Event 90512
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1765 bags
- Official record key
drug-enforcement:D-1269-2022
Official wording
Reason: Lack of Assurance of Sterility
Code information: Lots: NC2031A, Exp. 7/7/2022; NC2033A, Exp. 7/12/2022; NC2034A, Exp. 7/18/2022; NC2035A, Exp. 7/19/2022
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility