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FOOD AND DRUG ADMINISTRATION
FOR IMMEDIATE RELEASE

Consumer Media: 888-Info-FDA
January 13, 1999

PRODUCT
Nitroglycerin Extended Release (ER) Capsules, 2.5 mg, oral solid dosage form product packaged in 100 count bottles and in bulk cartons, Rx drug used in the prevention and treatment of angina pectoris associated with coronary artery disease. Brand name: "NITRO-TIME", distributed under the following labels: Time-Cap Labs Schein Pharmaceutical, United Research Laboratories (URL), Qualitest Pharmaceuticals. Recall #D-021-9.

CODE
Lot J051H, EXP date: 8/2000.
Time-Caps:  NDC 49483-221-10
Schein   :  NDC 0364-0174-01              
URL      :  NDC 0677-0485-01
Qualitest:  NDC 0603-4782-21

MANUFACTURER
Time-Cap Labs, Inc., Farmingdale, New York. Distributed under four different labels: Time-Cap Labs, Schein Pharmaceutical, URL, and Qualitest.

RECALLED BY
Manufacturer, by letter dated October 1, 1998. Firm-initiated recall ongoing.

DISTRIBUTION
Alabama, Arkansas, Florida, Illinois, Kentucky, Louisiana, Michigan, New Jersey, New York, Pennsylvania.

QUANTITY
15,918 100-count bottles and 353,940 bulk capsules were distributed.

REASON
Product fails content uniformity testing.

 

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.