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FOOD AND DRUG ADMINISTRATION
FOR IMMEDIATE RELEASE

Consumer Media: 888-Info-FDA
June 3, 1998

PRODUCT
Piroxicam Capsules, USP; for acute or long-term use in the relief of signs and symptoms of osteoarthritis and rheumatoid arthritis; packaged in bottles of 100, 500 & 1000 capsules:

a) 10mg, NDC #55953-617-40

b) 20 mg, NDC #55953-640-40, -70, -80 also packaged under the Moore label, NDC #0839-7774-06, -16; Major label, NDC #0904-5063-60, -40; and Mova label, NDC #55370-841-07.

Recall #D-156/157-8.

CODE
All lots within expiration date.

MANUFACTURER
Novopharm, Ltd., Scarborough, Ontario, Canada.RECALLED BY Novopharm USA, Inc., Schaumburg, Illinois, by letter dated May 8, 1998. Firm-initiated recall ongoing.

DISTRIBUTION
Nationwide.

QUANTITY
Amount distributed:
a) 15,390 100-capsule bottles
b) 52,366 100-capsule, 14,892 500-capsule and 5,147 1000-capsule bottles.

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.