April 12, 2000Eon 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:
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)
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 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
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