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Recall Observatory FDA recall evidence

Drug product

Lidocaine Hydrochloride and 5% Dextrose Injection, USP, 2g VIAFLEX Plus Plastic Container, 500mL, Rx Only, Baxter, Deerfield, IL 60015

D-627-2013

May 21, 2013

Class II

Product summary

Firm
Baxter Healthcare Corp.
Event
Event 65288
Status
Terminated
Classification
Class II
Quantity
N/A
Official record key
drug-enforcement:D-627-2013

Official wording

Reason: Lack of Assurance of Sterilty: 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 #: Product code 2B0973: P279935, Exp 7/13

Distribution pattern: Nationwide & Puerto Rico

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Lack of Assurance of Sterilty: 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.