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Safety Alerts
August 17, 1999

Rhone Poulenc Rorer Pharmaceuticals Recalls Arcola Indapamide 2.5 mg Tablets

Collegeville, PA (SafetyAlerts) - The Food and Drug Administration (FDA) today reported that Rhone Poulenc Rorer Pharmaceuticals is recalling Arcola Indapamide 2.5 mg Tablets because of dissolution failure.

PRODUCT
Indapamide 2.5 mg Tablets, in 100 and 1,000 tablet bottles, oral diuretic indicated for the treatment of hypertension, alone or in combination with other antihypertensive drugs. It is also indicated for the treatment of salt and fluid retention associated with congestive heart failure. This product is labeled under the firm's generic name Arcola. NDC 0070-3000-00 for the 100 count bottles and NDC 0070-3000-99 for the 1000 count bottles.

Recall #D-306-9.

CODE
Lot #MN3386 EXP 11/02 (bottles of 100)Lot #MN3396 EXP 11/02 (bottles of 1000).

MANUFACTURER
Rhone Poulenc Rorer Puerto Rico, Inc., Manati, Puerto Rico.

RECALLED BY
Rhone Poulenc Rorer Pharmaceuticals, Collegeville, Pennsylvania, by letter dated July 9, 1999. Firm-initiated recall ongoing.

DISTRIBUTION
Nationwide and the Caribbean.

QUANTITY
32,106 bottles of Lot MN3386 and 35,986 bottles of Lot MN3396 were distributed nationwide. 3,024 bottles of Lot MN3386 were sent to RPR Caribbean; firm estimates that very little of the two lots are left in commercial channels.

 

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.