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FOOD AND DRUG ADMINISTRATION
FOR IMMEDIATE RELEASE
Consumer Media: 888-Info-FDA
June 9, 1999

Allscripts, Inc. Recalls Indomethacin Extended Release Capsules

Libertyville, IL (SafetyAlerts) - The Food and Drug Administration (FDA) today reported that Allscripts, Inc. is recalling Indomethacin Extended Release Capsules because of Dissolution failure.

PRODUCT
Indomethacin Extended Release Capsules, USP, 75 mg, packaged in 7, 10, 14, 20 and 30 capsule unit containers, Rx non-steroidal anti-inflammatory drug used for the treatment of osteoarthritis, ankylosing spondylitis and rheumatoid arthritis, NDC #0258-3607-01

CODE
Product #1518-0:
lots 8230204, 8201099, 8161047, 8154080, 9048138, 9034225, 8266102, 8247110, 9076111, 9070061, 9050087
Product #1518-1:
lots 8166183, 8154081, 8258129, 8239032, 8253084, 8209090, 9006096, 8336136, 8335170, 8316110, 9096140, 9091075, 9084013, 9049091
Product #1518-2: 8303074, 8259121, 8247043, 8142062, 9085035, 9070002, 8355066, 8328097
Product #1518-3:
8237077, 8233057, 8230127, 8210077, 8341203, 8335171, 8327166, 8237157
Product #1518-6:
lots 9068141, 9067119, 9039184, 8362154, 8308179, 8307158, 8280168, 8160142, 8147139.

MANUFACTURER
Inwood Laboratories, Inc., Inwood, New York.

RECALLED BY
Allscripts, Inc., Libertyville, Illinois (repacker), by letter dated April 28, 1999. Firm-initiated recall ongoing. 
This is the first public notice issued by the FDA.

DISTRIBUTION
Indiana, Illinois, California, Missouri, Pennsylvania, Wyoming, Iowa, Maine, Nevada, Ohio, Colorado, Washington state, Florida, Tennessee, Michigan, Connecticut.

QUANTITY
62 bottles of 30, 300 bottles of 7, 280 bottles of 14, 91 bottles of 20 and 124 bottles of 10 capsules were distributed. Firm estimates that less than 25% of the product remained on the market at time of recall initiation.

Recall #D-237-9.

 

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.