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June 20, 2000

Goldline Brand Acetaminophen Suppositories Recalled

Bronx, NY (SafetyAlerts) - The Food and Drug Administration (FDA) today reported that Clay-Park Labs, Inc. is conducting a recall of Goldline brand Acetaminophen Suppositories, USP, OTC because the products were misbranded - Some 650 mg (correctly labeled) suppositories were packaged into cartons labeled as 120 mg.

Acetaminophen Suppositories, USP, OTC are indicated for the temporary relief of fever, ache, pains, and headaches, for rectal administration.

The affected products are:

  • 120 mg, Pediatric, units of 12, NDC #0182-1662-11

  • 650 mg, units of 12, NDC #0182-1095-11

The affected products are coded with lot #AL 606 EXP 9/20/02. The recalled products were distributed in Kentucky, approximately 49,392 suppositories were distributed.

This ongoing Class II recall was initiated by the company, by letter dated November 30, 1999.  This is the first public notice issued by the FDA.

Questions concerning this recall may be directed to the FDA at 1-888-INFO-FDA.
FDA Recall #d-404/405-0

Notice of this product warning was sent via email to SafeMail subscribers June 20, 2000.

Selected Recent Recalls

Health Professional:

Did you know?
During 2000 there were over
1050 products recalled in the United
States for safety reasons!

How many did you hear about?

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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.