Poulenc Rorer Recalls Tilade Inhaler
FOOD AND DRUG ADMINISTRATION
FOR IMMEDIATE RELEASE
Consumer Media: 888-Info-FDA
June 30, 1999
Collegeville, PA (SafetyAlerts) - The Food and Drug
Administration (FDA) today reported that Rhone Poulenc Rorer is recalling Tilade Inhaler
because of a failure to meet dose uniformity requirements.
Tilade Inhaler (Nedocromil Sodium Inhalation Aerosol)
1.75 mg per actuation, 8.5 g (52 metered inhalations) professional samples, an inhaled
anti-inflammatory agent for the preventive management of mild to moderate asthma in adult
and pediatric patients 6 years of age and older. NDC 0585-0685-98.
Lot #A70732 EXP 8/99.
Fisons PLC Pharmaceutical Division, United Kingdom.
Rhone Poulenc Rorer, Collegeville, Pennsylvania, by telephone on April 27, 1999,
followed by letter dated April 30, 1999. Firm-initiated recall complete.
Missouri and Arkansas.
16 inhalers were distributed; firm estimates none remain on the market.