Poulenc Rorer Pharmaceuticals Recalls Arcola Indapamide 2.5 mg Tablets
August 17, 1999
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.
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.
Lot #MN3386 EXP 11/02 (bottles of 100)Lot #MN3396 EXP 11/02 (bottles of 1000).
Rhone Poulenc Rorer Puerto Rico, Inc., Manati, Puerto Rico.
Rhone Poulenc Rorer Pharmaceuticals, Collegeville, Pennsylvania, by letter dated
July 9, 1999. Firm-initiated recall ongoing.
Nationwide and the Caribbean.
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.