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Recall Observatory FDA recall evidence

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

May 21, 2013

Class II

Product summary

Firm
Baxter Healthcare Corp.
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

    reason.sterility_assurance · v1.0.0

    Lack of Assurance of Sterility