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U.S. Department of Health and Human Services

Class 1 Device Recall One Touch

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 Class 1 Recall
One Touch
see related information
Date Posted March 03, 2007
Recall Status1 Terminated on June 08, 2007
Recall Number Z-0547-2007
Recall Event ID 37307
Product Classification System, Test, Blood Glucose, Over The Counter - Product Code NBW
Product One Touch Basic/Profile and One Touch Ultra-Blood Glucose Test strips- 50-count
Code Information One Touch Ultra Test Strips: Lot #''s: 2691191, 2691261. One Touch Ultra Basic/Profile Test Strips- Lot #''s 272894A, 2619932, 2606340, 2651211.
Recalling Firm/
Manufacturer
Safety & Supplies Co. Inc.
17 Edgeboro Rd
East Brunswick, New Jersey 08816-1600
For Additional Information Contact Ahmed Anjum
732-698-1600
Manufacturer Reason
for Recall
Counterfeit product (manufacturer unknown)
FDA Determined
Cause 2
COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Counterfeit
Action A recall notification was sent on February 1, 2007 via first class mail to all customers.
Quantity in Commerce Unknown
Distribution Nationwide to pharmacies.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
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