September 27, 2000Diabetes Testing Solution
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.
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.
All lots manufactured on or after August 1999.
Irenda Corporation, Los Angeles, California (contract manufacturer)
Breen Labs, Los Angeles, California (responsible firm/distributor), by letter on July 6,
2000. Firm-initiated recall ongoing.
44,231 bottles were distributed.
Questions concerning this recall may be directed
to the FDA at 1-888-INFO-FDA.
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