June 20, 2000Goldline Brand Acetaminophen
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
The affected products are:
120 mg, Pediatric, units of 12, NDC
650 mg, units of 12, NDC
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.
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