Drug recall D-625-2013
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
Reason for recall
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.
Lots and codes
Lot #: a) Product code 2B0088: P280115, P285239, Exp 7/13; b) Product code 2B0089: P280230, P280461, P285288, P285288A, P285783, Exp 8/13
Recall details
- Recalling firm
- Baxter Healthcare Corp., Deerfield, IL
- Quantity
- 730,848 units
- Distribution
- Nationwide & Puerto Rico
- Type
- Voluntary: Firm initiated
- Recall initiated
- May 21, 2013
- Terminated
- June 18, 2015
Related products
- Dextrose – drug information
- NDC 0338-0023 Dextrose · Dextrose Monohydrate 100 g/1000mL · Baxter Healthcare Corporation
- NDC 0338-0017 Dextrose · Dextrose Monohydrate 50 g/1000mL · Baxter Healthcare Corporation