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
FIRST ARTICLE / WEEKLY
What cleared, what was recalled, and what changed in the standards. One edition a week for the people who make medical devices.
