|FOOD AND DRUG
FOR IMMEDIATE RELEASE
Consumer Media: 888-Info-FDA
January 13, 1999
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
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
Time-Cap Labs, Inc., Farmingdale, New York. Distributed under four different labels:
Time-Cap Labs, Schein Pharmaceutical, URL, and Qualitest.
Manufacturer, by letter dated October 1, 1998. Firm-initiated recall ongoing.
Alabama, Arkansas, Florida, Illinois, Kentucky, Louisiana, Michigan, New Jersey, New York,
15,918 100-count bottles and 353,940 bulk capsules were distributed.
Product fails content uniformity testing.