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FOOD AND DRUG ADMINISTRATION
FOR IMMEDIATE RELEASE

Consumer Media: 888-Info-FDA
March 31, 1999

PRODUCT
a) (OTC) Ballistic Tablets, Expectorant/Bronchodilator (Ephedrine
HCL 25mg Guaifenesin 100 mg) in 100 tablet bottles;
b) (OTC) SinuCheck Capsules (Pseudoephedrine HCL from Ephedra
Sinensis-30mg) in 60 capsule bottles;
c) (OTC) AllerClear Capsules (Pseudoephedrine HCL from Ephedra
Sinensis-30mg) in 90 capsule bottles.  Recall #D-148/150-9.

CODE
Lot Numbers:  a) 0798-08, 0798-38, and 0998-11
b) 0898-10, 0898-07, and 0998-48
c) 0898-09, 0998-08, and 0998-09.

MANUFACTURER
Nassmith Pharmaceuticals, Inc., Oceanside, California.

RECALLED BY
Manufacturer, by fax and letter on February 11, 1999. Firm-initiated recall complete.

DISTRIBUTION
Utah and Wisconsin.

QUANTITY
     Lot No.    Amt.dist.   Amt. In Commerce
a)  0798-08     728,648     728,648 Tablets
    0798-38     731,497     731,497 Tablets
    0998-11     736,600     736,600 Tablets
b)  0898-10     199,821     199,821 Capsules
    0898-07     394,890     394,890 Capsules
    0998-48     198,959     198,959 Capsules
c)  0898-09     273,361     273,361 Capsules
    0998-08     275,853     275,853 Capsules
    0998-09     264,953     264,953 Capsules.

REASON
Current good manufacturing practice deviations including but limited to; Lack of raw material, in-process and finished product testing and Lack of manufacturing validation and stability data to support labeled expiry.

 

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.