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SafetyAlerts
September 27, 2000

Diabetes Testing Solution Recalled

Los Angeles, CA (SafetyAlerts) - The Food and Drug Administration (FDA) has announced that Breen Labs is recalling its Glucose Tolerance Test Beverage, (Carbonate), Cola, Lemon Sour, and Orange Flavors, 100 gms D-Glucose, in 10-fluid ounce bottles, under the
brand Qualadex because of subpotency.

This is the first public notice of this Class II recall issued by FDA.

PRODUCT
Glucose Tolerance Test Beverage, (Carbonate), Cola, Lemon Sour, and Orange Flavors, 100 gms D-Glucose, in 10-fluid ounce bottles, under the brand Qualadex, OTC used as a diagnostic test solution for diabetes testing.

Recall #D-191-0.

CODE
All lots manufactured on or after August 1999.

MANUFACTURER
Irenda Corporation, Los Angeles, California (contract manufacturer)

RECALLED BY
Breen Labs, Los Angeles, California (responsible firm/distributor), by letter on July 6, 2000. Firm-initiated recall ongoing.

DISTRIBUTION
California.

QUANTITY
44,231 bottles were distributed.

Questions concerning this recall may be directed to the FDA at 1-888-INFO-FDA.

 
Selected Recent Recalls


Health Professional:

Did you know?
During 2000 there were over
1050 products recalled in the United
States for safety reasons!

How many did you hear about?

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