Drug product
5% Dextrose Injection, USP, in VIAFLEX Plastic Container Multi Pack, Rx Only, a) 50 mL (NDC 0338-0017-31), b) 100 mL (NDC 0338-0017-38), Baxter, Deerfield, IL 60015
D-625-2013
Product summary
- Event
- Event 65288
- Status
- Terminated
- Classification
- Class II
- Quantity
- 730,848 units
- Official record key
drug-enforcement:D-625-2013
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 2B0088: P280115, P285239, Exp 7/13; b) Product code 2B0089: P280230, P280461, P285288, P285288A, P285783, Exp 8/13
Distribution pattern: Nationwide & Puerto Rico
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility