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FOOD AND DRUG ADMINISTRATION
FOR IMMEDIATE RELEASE

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

PRODUCT
Nitroglycerin Capsules, Rx drug used in the prevention and
treatment of angina pectoris associated with coronary artery
disease in bottles of 60 and 100, under the following labels:
Time-Cap, URL, Ethex, Goldline, Kenwood, Qualitest, and Rugby:
a) Nitroglycerin Capsules, Extended Release, 2.5 mg
NDC numbers: 49483-221-10 (Time-Cap Labs 100 capsules),
             0482-1025-01 (Kenwood 100 capsules)
             0603-4782-21 (Qualitest 100 capsules)
             58177-004-03 (Ethex 60 capsules)
             58177-004-04 (Ethex 100 capsules)
             0536-4083-01 (Rugby 100 capsules)
             0677-0485-01 (URL 100 capsules)
b) Nitroglycerin Capsules, Extended Release, 6.5 mg
NDC numbers: 49483-222-06 (Time-Cap Labs 60 capsules)
             0482-1065-01 (Kenwood 100 capsules)
             0603-4783-21 (Qualitest 100 capsules)
             0182-0703-01 (Goldline 100 capsules)
             0536-4084-01 (Rugby 100 capsules)
             0677-0486-01 (URL 100 capsules)
c) Nitroglycerin Capsules, Extended Release, 9.0 mg
NDC numbers: 49483-223-06 (Time-Cap Labs  60 capsules)
             49483-223-10 (Time-Cap Labs 100 capsules)
             0482-1090-01 (Kenwood 100 capsules)
             0603-4784-20 (Qualitest  60 capsules)
             0182-1670-26 (Goldline 60 capsules)
             58177-006-03 (Ethex 60 capsules)
             58177-006-04 (Ethex 100 capsules)
             0536-4090-08 (Rugby 60 capsules)
             0677-0967-06 (URL 60 capsules).
Recall #D-201/203-8.

CODE
Lot numbers: a) F056H EXP 6/2000, G024H EXP 7/2000, J062H EXP 9/2000; b) C046H EXP 3/2000, D036H EXP 4/2000, F044H EXP 6/2000; c) D005H EXP 4/2000.

MANUFACTURER
Time-Cap Labs, Inc., Farmingdale, New York.

RECALLED BY
Manufacturer, by letter dated June 8, 1998, followed by telephone. Firm-initiated recall ongoing.

DISTRIBUTION
Alabama, Arkansas, Connecticut, Florida, Illinois, Kentucky, Louisiana, Michigan, Missouri, New Jersey, New York, Ohio, Pennsylvania, Tennessee, Puerto Rico, Canada.

QUANTITY
a) 3,615 60-count bottles; 53,943 100-count bottles, and 281,204 bulk capsules; b) 9,809 60-capsules bottles, 33,381 100-capsule bottles and 652,268 bulk capsules; c) 11,280 60-capsule bottles and 2,688 100-capsule bottles were distributed.

REASON
Unapproved ingredient used in manufacturing.

 

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.