Updated October 5, 1999
Hygroton Tablets Recalled for
Collegeville, PA (SafetyAlerts) -- The FDA today issued
notice that Rhone Poulenc Rorer, Collegeville, Pennsylvania, is continuing its recall of
its Hygroton Tablets, a Rx oral diuretic. The recall is being conducted due to
dissolution failure discovered during routine testing.
Recall of the product was initiated by the
manufacturer - by letter dated April 16, 1999, distribution was nationwide. The
FDA's description of the product is as follows:
"a) Hygroton Tablets (chlorthalidone, USP), 50
mg, in 100 tablet bottles, NDC 0075-0020-00;
b) Hygroton Tablets (chlorthalidone, USP), 25 mg, in 100 tablet bottles
The product identification codes are listed as:
a) MN3117 EXP 6/30/00 and MN2528 EXP 9/30/00;
b) MN2523 EXP 8/31/99 and MN2428 EXP 8/31/99.
C) New Lot Numbers added Oct 5, 1999 - MN2564 and MN2882 EXP
The firm estimated that 3,000 units of the 50 mg
tablets and approximately 3,000 units of the 25 mg tablets remained on market at time of
This recall has been certified as a Class III recall by the FDA.
Questions concerning this recall may be directed
to the Food and Drug Administration at 1-800-INFO-FDA. The reference number is: Recall
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