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