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FOOD AND DRUG ADMINISTRATION
FOR IMMEDIATE RELEASE

Consumer Media: 888-Info-FDA
April 29, 1998

PRODUCT
Rugby brand Bromanate Elixir (Bromaline),
(Phenylpropanolamine Hydrochloride 12.5
mg/Brompheniramine Maleate 2 mg), in 4 fluid ounce
bottles, Rx indicated for the temporary relief of
runny nose and sneezing, itching of the nose or
throat, and itchy watery eyes, due to hay fever
and nasal congestion due to the common cold. NDC
#0536-2345-97.

Recall #D-117-8.

CODE

Lot #RB 7198 EXP 5/99.

MANUFACTURER

Alpharma, U.S. Pharmaceuticals Division,
Baltimore, Maryland.

RECALLED BY

Manufacturer, by telephone on March 20, 1998, and
by letter on March 30, 1998. Firm-initiated
recall ongoing.

DISTRIBUTION

Georgia.

QUANTITY

60,048 units were distributed.

REASON

Superpotent (Brompheniramine Maleate).

 

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.