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Recall Observatory FDA recall evidence

Drug product

Practi-0.9% Sodium Chloride, 50 mL, 100 mL, 250 mL, 500 mL, and 1000 mL bags, Product of China, Wallcur, San Diego, CA, 92111, USA; Wallcur Practi Products for Clinical Simulation; NDCs 5108-0954-75, 5108-0954-71, 5108-0954-72, 5108-0954-74, 5108-0954-73.

D-0434-2015

January 06, 2015

Class I

Product summary

Firm
Wallcur Incorporated
Event
Event 70155
Status
Terminated
Classification
Class I
Quantity
18,657 Bags
Official record key
drug-enforcement:D-0434-2015

Official wording

Reason: Non-sterility: Product is made in a non-sterile facility and is not intended for use in humans or animals.

Code information: No unique lot number on product; all Practi-0.9% Sodium Chloride is subject to recall.

Distribution pattern: United States including Puerto Rico; and Canada

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Non-sterility: Product is made in a non-sterile facility and is not intended for use in humans or animals.