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FOOD AND DRUG ADMINISTRATION
FOR IMMEDIATE RELEASE

Consumer Media: 888-Info-FDA
July 22, 1998

PRODUCT
Piroxicam Capsules, USP, Rx, for acute or long-term use in the relief of signs and symptoms of osteoarthritis and rheumatoid arthritis, packaged by Allscripts:

a) 10 mg capsules, packaged in bottles of 21 capsules, NDC #54569-3974-0

b) 20 mg capsules, packaged in bottles of: 14 capsules, NDC #54569-3693-0; 10 capsules, NDC #54569-3693-1 7 capsules, NDC #54569-3693-2; 20 capsules, NDC #54569-3693-3 30 capsules, NDC #54569-3693-4; 15 capsules, NDC #54569-3693-5.

Recall #D-198/199-8.

CODE
Lot numbers: a) 6323030, 7027038, 7031020, 7035072, 7035102, 7052045, 7097123, 7142140, 7167030, 7174071, 7174093, 7176113, 7188107, 7260077, 7316095, 7323076, 7336137, 7342058 b) 6326092, 7318074, 6317095, 7062139, 6338149, 7316165, 7324091, 6323095, 6311129, 6331073.

MANUFACTURER
Novopharm Ltd., Scarborough, Ontario, Canada (responsible firm).

RECALLED BY
Allscripts, Inc., Libertyville, Illinois, by letter dated June 8, 1998. Firm-initiated recall ongoing.

DISTRIBUTION
California, Ohio, Washington, New Hampshire, Kansas, Florida, Louisiana, New Mexico, Mississippi, Georgia, Tennessee, Iowa, Idaho, Missouri, Michigan, Indiana, Illinois and South Dakota.

QUANTITY
552 bottles of 21 - 10 mg capsules, and 283 bottles of 14, 166 bottles of 10, 306 bottles of 7, 55 bottles of 20, 99 bottles of 30 and 84 bottles of 15 - 20 mg. capsules were distributed. The firm estimates that less than 25% of the product remains on the market.

REASON
Lack of blend uniformity assurance.

 

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.