D-0434-2015 Class I Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- April 15, 2015
- Initiation Date
- January 6, 2015
- Termination Date
- November 25, 2015
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 18,657 Bags
Product Description
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.
Reason for Recall
Non-sterility: Product is made in a non-sterile facility and is not intended for use in humans or animals.
Distribution Pattern
United States including Puerto Rico; and Canada
Code Information
No unique lot number on product; all Practi-0.9% Sodium Chloride is subject to recall.