GSK Pulls Drug Manufactured at Troubled Novartis Plant

GSK Pulls Drug Manufactured at Troubled Novartis Plant

March 5th, 2012 // 1:34 pm @

GlaxoSmithKline ($GSK) is the latest victim of a contract-manufacturing snafu. The company has recalled 394,230 bottles of its DynaCirc CR blood pressure drug over fears that other tablets made at the same plant might have been mixed into the packages.

The plant in question is a Novartis ($NVS) facility in Lincoln, NE, that’s currently on hold for manufacturing fixes. The FDA issued a Form 483 inspection report on shortfalls at the plant, citing the potential for drug mix-ups because of problems on a packaging line. Novartis has recalled several products made there, including Excedrin and No-Doz, because of potential packaging mistakes. Endo Pharmaceuticals ($ENDP) warned that supplies of 9 pain drugs could be affected by the suspension of production.

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GSK says the DynaCirc recall is “based on information provided by Novartis, of inconsistent packaging line-clearance practices at their Lincoln, Nebraska facility, which could potentially result in tablet mix-ups for products packaged” there, Dow Jones reports. The recall affects GSK’s entire DynaCirc supply in the U.S., so patients will have to turn to alternative treatments. When Novartis will resume production–and when GSK can resume supplying the drug–isn’t clear, Dow Jones notes.

The DynaCirc shortage is just the latest supply problem spawned by manufacturing woes. Ben Venue Laboratories, which manufactures injectables for other drugmakers and under its own label, Bedford Laboratories, had to shut down an Ohio plant for retooling after FDA inspectors found a host of violations. Some drugs produced there have been recalled, while others are running short because of the production overhaul.


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