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Safety Alerts
Updated October 5, 1999

Hygroton Tablets Recalled for Dissolution Failure

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 NDC 0075-0022-00."

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 9/30/99

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 recall initiation.

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 #D-262/263-9.

Safety Alerts compiles comprehensive safety recall information for the United States. SafeMail is a free email service to warn consumers of faulty products and contaminated foods. For complete information regarding current recalls, past recalls and timely product warning notification visit: www.safetyalerts.com.

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The information contained herein has been obtained from sources that the Company believes to be reliable, however, the Company has not independently verified or confirmed the information and the recipient acknowledges that no representations or warranties are being made in connection with the use of the information.