Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-0399-03

Genuine One Touch Glucose 50 Test Strips, For the quantitative measure of glucose in whole blood, LIFESCAN, a...

River City Drug / initiated 2002-10-08 / Terminated / root cause: labeling and UDI

River City Drug began a recall of Genuine One Touch Glucose 50 Test Strips, For the quantitative measure of glucose in whole blood, LIFESCAN, a Johnson & Johnson Company, Milpitas California... on . The reason FDA records is "Products labeled 'For Sale Outside The USA and Canada,' were being offered for sale in the U.S". As of , the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number
Z-0399-03
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
River City Drug
Product
Genuine One Touch Glucose 50 Test Strips, For the quantitative measure of glucose in whole blood, LIFESCAN, a Johnson & Johnson Company, Milpitas California 95035, For Sale Outside of the USA and Canada, Lot 1666680A Exp. 2003-11. Product is packed two vials of 25 strips per vial.
Product code
JJQ Colorimeter, Photometer, Spectrophotometer For Clinical Use
Reason for recall
Products labeled 'For Sale Outside The USA and Canada,' were being offered for sale in the U.S.
Root cause tag
labeling and UDI
FDA root cause
Other
Action
Letters were sent via regular mail to customers on/about 10/08/02 with a response card attached. Customers were informed of the recall, and were urged to contact their accounts and to return their outstanding recall stock to River City Drug for full credit.
Quantity in commerce
3024 units
Distribution
Nationwide. AZ, CA, DE, FL, GA, KY, KS, HI, IA, IL, LA, MA, MD, MI, MN, MO, NC, NM, NV, OH, OK, PA, SC, SD, TN, TX, VA, WA, WI, WV. There are no foreign or government accounts involved.
Product codes and lots
Lot# 1666680A Exp. 2003-11