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FOOD AND DRUG ADMINISTRATION
FOR IMMEDIATE RELEASE
Consumer Media: 888-Info-FDA
May 19, 1999

Tylenol,   Ventolin,  Dimetapp,  Donnatal, Benadryl, Maalox, and other Over the Counter Medications Recalled

Rogersville, TN (SafetyAlerts) - The Food and Drug Administration (FDA) today reported that Rural Health Services Consortium Inc. is recalling certain medicines sold over-the-counter because of the lack of data to support labeled expiration date.

PRODUCT
a) Acetaminophen liquid, alcohol free, sugar free, "Tylenol", 160mg/5mL, in 120 mL units;
b) Albuterol Sulfate Syrup, "Ventolin", 2mg/5mL, in 120 mL units;
c) Sulfamethoxazole/Trimethoprim Syrup, "Bactrim", 200/40mg, in 120mL units;
d) Phenylpropanolamine/Brompheniramine Elixir, "Dimetapp" 12.5/2 mg, in 120 mL units;
e) Belladonna Alkaloids w/Phenobarbital Elixir, "Donnatal" 12.5 mg/5 mL in 120 mL;
f) Diphenhydramine Elixir, "Benadryl", 12.5 mg/5 mL, OTC in 120 mL units;
g) Erythromycin Ethylsuccinate Suspension, 200 mg/5 mL, in 200 mL units;
h) Maalox-Donnatal Mix (1:1 mix-Liquid) Rx in 180 mL units;
i) Maalox-Donnatal-Lidocaine Mix (3:2:1-liquid) in 360 mL units;
j) Maalox-Lidocaine Mix (2:1-liquid)in 360 mL units;
k) Promethazine Syrup, "Phenergan", (6.25mg/5mL) in 120 mL units;
l) Theophylline-Guaifenesin Elixir, Theolate "Elixophylline GG", in 480mL units.

Recall #D-209/220-9.

CODE
All lot codes.

MANUFACTURER
Rural Health Services Consortium Inc., Rogersville, Tennessee.

RECALLED BY
Manufacturer, by letter December 14, 1998. Firm-initiated recall complete.

DISTRIBUTION
Tennessee.

QUANTITY
Undetermined.

 

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.