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FOOD AND DRUG ADMINISTRATION
FOR IMMEDIATE RELEASE

Consumer Media: 888-Info-FDA
March 25, 1998

PRODUCT
Prevpac Triple Therapy (lansopazole capsules 30
mg/Amoxicillin capsules 500 mg/Clarithromycin
tablets 500 mg), Rx, used for the treatment of
duodenal ulcers associated with H. Pylori. NDA
50-757; NDC 0300-3702-01 on commercial box of 14
daily patient packs (blister cards), NDC
0300-3702-10 on professional sample daily patient
pack, NDC 0300-3702-11 on commercial single daily
patient pack; NDC 0300-3702-00 on professional
sample box of 14 daily patient packs; 14 daily
patient packs per package, 8 packages per case.

Recall #D-105-8.

CODE

Lot #35 001 2Z EXP 08/99.

MANUFACTURER
Anderson Packaging, Rockford, Illinois (contract
packager).

RECALLED BY

Tapp Pharmaceuticals, Inc., Deerfield, Illinois,
by letters dated January 30, 1998, and February 2,
1998. Firm-initiated recall ongoing.

DISTRIBUTION

West Virginia, California, Oregon, Illinois,
Tennessee, New York, North Carolina, New Mexico,
Missouri, Colorado, Indiana, Texas, Minnesota,
Louisiana, Maryland, Massachusetts, Alabama,
Idaho, Connecticut, Georgia, Mississippi.

QUANTITY

1,434 cases were distributed

REASON

Mislabeling - Some product labeled as
"professional samples, not for sale" were released
for sale.

 

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.