|FOOD AND DRUG
FOR IMMEDIATE RELEASE
Consumer Media: 888-Info-FDA
March 25, 1998
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.
Lot #35 001 2Z EXP 08/99.
Anderson Packaging, Rockford, Illinois (contract
Tapp Pharmaceuticals, Inc., Deerfield, Illinois,
by letters dated January 30, 1998, and February 2,
1998. Firm-initiated recall ongoing.
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.
1,434 cases were distributed
Mislabeling - Some product labeled as
"professional samples, not for sale" were released