Drug product
0.9% Sodium Chloride Injection, USP, in MINI-BAG Plus Container, a) 50 mL (NDC 0338-0553-11), b) 100 mL (NDC 0338-0553-18), Rx Only, Baxter, Deerfield, IL 60015
D-624-2013
Product summary
- Event
- Event 65288
- Status
- Terminated
- Classification
- Class II
- Quantity
- 845,520 units
- Official record key
drug-enforcement:D-624-2013
Official wording
Reason: Lack of Assurance of Sterility: Specific lot numbers of these products have been identified for potential administration port leakage. The potential for leakage is the result of a manufacturing issue which occurred during the sealing of the closure assembly at the administration port.
Code information: Lot #: a) Product code 2B0042: P285668, P285668A, P285668C, P285734, Exp 5/13; b) Product code 2B0043: P285395, Exp 5/13
Distribution pattern: Nationwide & Puerto Rico
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility