GSK recalls Novartis’ blood pressure drug
pharmafile | February 28, 2012 | News story | Manufacturing and Production |Â Â DynaCirc CR, GSK, NovartisÂ
GlaxoSmithKline is the latest company to be affected by manufacturing glitches at Novartis’ troubled facility in Lincoln, Nebraska, having been forced to issue a recall of nearly 400,000 bottles of a blood pressure drug made there.
Novartis temporarily suspended production at the plant in January in the wake of an FDA warning letter, which also found violations at other plants in the company’s manufacturing network.
A hallmark of the problems encountered at the facility has been mix-ups in packaging with some medicines found to contain doses of other products, and GSK’s latest case conforms to that trend.
In its enforcement report, the FDA notes that 394,230 30-count bottles of DynaCirc CR (isradipine) 5mg and 10mg blood pressure tablets, are being recalled by GSK “due to compliance concerns regarding the level of cGMP compliance and procedural controls related to line clearance during the packaging process at the Novartis Consumer Health”.
Novartis has recalled a number of over-the-counter products made at the Lincoln plant, while Endo Pharmaceuticals has also experienced supply disruptions to several painkiller medicines manufactured there on its behalf.
Meanwhile, this is not the first time that GSK has been forced to order a recall of DynaCirc CR made at Novartis’ facility. In March 2011 the company recalled nearly 25,000 bottles of the medicine after it failed dissolution testing requirements.
GSK’s recall affects just about all the supplies currently on the US market, so patients taking DynaCirc CR will have to switch to alternative treatments while the shutdown is ongoing.
According to the FDA’s website, the agency issued a Form 483 report for the Lincoln facility after an inspection in August 2011 revealed a number of GMP violations, including deficiencies in the operations of its quality control unit.
That inspection revealed 166 complaints of foreign tablets in drug products made at the plant since 2009.
Phil Taylor
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