Safety Alerts Saves Lives
Safety Alerts  
 
Home Privacy About Us Contact Us Change Preferences
" "
FOOD AND DRUG ADMINISTRATION
FOR IMMEDIATE RELEASE
Consumer Media: 888-Info-FDA
June 30, 1999

Rhone Poulenc Rorer Recalls Tilade Inhaler

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.

PRODUCT
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.

Recall #D-276-9.

CODE
Lot #A70732 EXP 8/99.

MANUFACTURER
Fisons PLC Pharmaceutical Division, United Kingdom.

RECALLED BY
Rhone Poulenc Rorer, Collegeville, Pennsylvania, by telephone on April 27, 1999, followed by letter dated April 30, 1999. Firm-initiated recall complete.

DISTRIBUTION
Missouri and Arkansas.

QUANTITY
16 inhalers were distributed; firm estimates none remain on the market.

 

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.