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FOOD AND DRUG ADMINISTRATION
FOR IMMEDIATE RELEASE

Consumer Media: 888-Info-FDA
March 24, 1999

PRODUCT
Epinephrine Inhalation Aerosol, USP, 5.5 mg/ml, 1/2 ounce (15ml), for the temporary relief of shortness of breath, tightnessof chest, and wheezing due to bronchial asthma disorders,distributed under the Walgreen, Osco, Eckerd, CVS, Menley andJames, Marquee, Longs, Select Brands, Drug Guild, Sav-on,American Fare, Major, Quality Choice and Rite Aid labels.Recall #D-140-9.

CODE
Lot No.   NDC No.         Size      Exp Date   Label
RN7836   11917-003-93     15 ml    04/00       Walgreens
         12810-970-99     15 ml    04/00      Osco Drug
         19458-5066-1     15 ml    04/00      Eckerd
         50428-583-20     15 ml    04/00      CVS
         87900-970-99     15 ml    04/00      Menley & James
RN7839   076-00970-15     15 ml    04/00       Marquee
         12333-9477-1     15 ml    04/00      Longs
         15127-970-15     15 ml    04/00      Select Brands
         19458-9001-1     15 ml    04/00      Eckerd
         26032-970-15     15 ml    04/00      Drug Guild
         37097-970-15     15 ml    04/00      Sav-on
         7200-1755-4       15 ml    04/00       American Fare
RN7841   0904-7770-35     15 ml    05/00       Major
         11161-970-99     15 ml    05/00      Quality Choice
         11822-3479-7     15 ml    05/00      Rite Aid
         11917-003-93     15 ml    05/00      Walgreens
         12810-970-99     15 ml    05/00      Osco Drug
         7200-1755-5       15 ml    05/00       American
Fare.

MANUFACTURER
Alpharma, U.S. Pharmaceutical Division, Baltimore, Maryland.

RECALLED BY
Manufacturer, by letter on or about January 20, 1999. Firm-initiated recall ongoing.

DISTRIBUTION
Nationwide.

QUANTITY
Lot No.       NDC             SHIPPED 
RN7836    11917-003-93       13860     
          12810-970-99        5976     
          19458-5066-1        9900     
          50428-583-20        72       
          87900-970-99        22704    
RN7839    076-00970-15       2844      
          12333-9477-1        3996     
          15127-970-15        4356     
          19458-9001-1        13212    
          26032-970-15        1368     
          37097-970-15        2844     
          7200-1755-4         12384    
RN7841    0904-7770-35       2844      
          11161-970-99        2844     
          11822-3479-7        10368     
          11917-003-93        14796     
          12810-970-99        4284      
          7200-1755-5         9720.

REASON
Failure to meet the USP criteria for unit spray and total doses.

 

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.