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Actelion Updates Tracleer Labeling

Date: 3/3/2006

Reason: Cases of hepatotoxity reported.
Distribution: Nationwide.

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The Food and Drug Administration (FDA) released the following information:

Actelion and the FDA notified healthcare professionals of changes to the prescribing information of Tracleer (Bosentan) based on cases of hepatotoxity reported. The notification underscored the need to continue monthly liver function monitoring for the duration of Tracleer treatment and the need to adhere to the recommended dosage adjustment and monitoring guidelines described in the product labeling.

Other Drugs / Medicines Recalls and Alerts of Interest

Medtronic Initiates Voluntary Field Actions for Selected Heparin-Coated Products Used During Cardiopulmonary Bypass

Date: 6/12/2008

Reason: Limited lots of Carmeda-coated products were manufactured with heparin found to have been contaminated with oversulfated chondroitin sulfate (OSCS).

Distribution: Nationwide

Atrium Initiates Voluntary Recall Action Regarding HYDRAGLIDE™ Brand Heparin-Coated Thoracic Drainage Catheters used for Autotransfusion during Cardiopulmonary Bypass Surgery

Date: 6/12/2008

Reason: Limited lots of Atrium heparin-coated Hydraglide Thoracic Catheters were manufactured with heparin found to have been contaminated with oversulfated chondroitin sulfate (OSCS)

Distribution: Nationwide

Medicis Announces Voluntary Recall of Solodyn® (minocycline HCL, USP) 90 Mg Tablets, Extended Release; Lot Numbers B080037 and B080038 Due to Product Mix-Up

Date: 6/12/2008

Reason: Taking AZASAN® instead of SOLODYN® presents a health hazard and safety risk to patients

Distribution: Nationwide

ETHEX Corporation Voluntarily Recalls Specific Lots of 30 mg. and 60 mg. Morphine Sulfate Extended Release Tablets Due to the Potential for Oversized Tablets NDC #58177-320-04 & 58177-330-04 Lot Numbe

Date: 6/16/2008

Reason: Oversized tablets may contain as much as two times the labeled level of active morphine sulfate

Distribution: Nationwide

International Pharmaceuticals, Ltd. Issues a Voluntary Recall of all Viril-Ity-Power (VIP) Tabs, a Product Marketed as a Dietary Supplement

Date: 6/12/2008

Reason: it contained a potentially harmful undeclared ingredient, hydroxyhomosildenafil

Distribution: Nationwide

ETHEX Corporation Voluntarily Recalls a Single Lot of Morphine Sulfate 60 mg Extended Release Tablets Due to the Potential for Oversized Tablets

Date: 6/12/2008

Reason: Oversized tablets may contain as much as two times the labeled level of active morphine sulfate

Distribution: Nationwide

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Drugs / Medicines Recalls and Alerts

Actelion Updates Tracleer Labeling

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