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SafetyAlerts
April 12, 2000

Eon Labs Manufacturing, Inc Recalls Isoxsuprine HCL Tablets

Laurelton, NY (SafetyAlerts) - The Food and Drug Administration (FDA) today reported that Eon Labs Manufacturing Inc is recalling Isoxsuprine HCL Tablets because of dissolution failure (42 month stability).

The recalled Isoxsuprine HCL Tablets, 10 mg and 20 mg, USP, in 100 and 1,000 tablet bottles, is a prescription indicated for the relief of symptoms associated with cerebral vascular insufficiency.  The recalled product was sold under the following labels:

Eon:
NDC 0185-0530-01 (10 mg, bottles of 100s)
NDC 0185-0530-10 (10 mg, bottles of 1000s)
NDC 0185-0531-01 (20 mg, bottles of 100s)
NDC 0185-0531-10 (20 mg, bottles of 1000s)

Major:
NDC 0904-0635-60 (10 mg, bottles of 100s)
NDC 0904-0636-60 (20 mg, tablets of 100s)
NDC 0904-0636-80 (20 mg, bottles of 1000s).

According to the FDA, approximately 92,000 units were distributed nationwide. All lots within expiration date are affected by this recall.

This ongoing Class III recall was initiated by Eon Labs Manufacturing Inc., by letters dated November 19, 1999, January 12, 2000, and February 3, 2000.  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-259/260-0

 
Selected Recent Recalls


Health Professional:

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

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