January 2015 FDA Recall Drug by Wallcur Incorporated
D-0434-2015 - Non-sterility

This Class I drug recall was voluntarily initiated by Wallcur Incorporated on January 6, 2015 for the product Drug. The FDA reported the reason for recall as non-sterility. The product was distributed in United States including Puerto Rico; and Canada and the recall is currently terminated.

Recall Number: D-0434-2015

Reason for Recall
Non-sterility: Product is made in a non-sterile facility and is not intended for use in humans or animals.
Initiated
01-06-2015
Reported
04-15-2015
Quantity
18,657 Bags

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
70155
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class I - is a situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Wallcur Incorporated
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
E-Mail
Distribution Pattern About Distribution Pattern
General area of initial distribution.
United States including Puerto Rico; and Canada
Termination Date About Termination Date
Date that FDA officially terminated the recall.
11-25-2015
Product Description About Product Description
Full technical description of the 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.

Batch or Lot Expiration Information

Lot# No unique lot number on product; all Practi-0.9% Sodium Chloride is subject to recall.