Monday, September 27, 2010

Schering-Plough: Hong Kong's Supply of PegIntron® Redipens™ Possibly Defective

According to published reports out of Hong Kong -- some of the in-country PegIntron® Redipens have exhibited a propellant-gas leak, resulting in uneven dosing. Here's a snippet:

. . . .According to Schering-Plough, the defect is related to individual Redipen device and it may affect the product quality, with possible safety consequence. Based on available information in hand, it is estimated that the defect occurred with a frequency of about 3 in 20,000.

Records in Schering-Plough showed that the products have been supplied to 10 medical practitioners and three local hospitals. Due to the low prevalence of the defect and no readily available stock replacement, Schering-Plough proposed to send medical representatives to visit all involved doctors and hospitals to inspect their stock before being utilised. Healthcare professionals should only administer the products to patients after Schering-Plough has confirmed that their products are satisfactory.

After risk assessment, DH endorsed the above proposal. Meanwhile, DH is also liaising with leading overseas authorities about the issue and will continue to monitor the wholesaler's inspection. . . .

We'll keep a weather-eye on this horizon.

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