FDA Warns Sandoz About Possible Quality-Control Problems At Its North Carolina Generic Drug Manufacturing Facility

Inspection Found Sandoz Failed To Properly Validate Manufacturing Process For Metoprolol Succinate ER Tablets (Generic Form Of Toprol XL) Before Distributing Pills

(Posted by Tom Lamb at DrugInjuryWatch.com)

There is yet another apparent quality-control problem in the generic drug manufacturer sector.  This one involves Sandoz, the generic drug unit of Novartis AG (NVS), and its metoprolol succinate ER tablets, which is a generic form of AstraZeneca's Toprol XL.

An August 26, 2008 Reuters article, "UPDATE 1-US warns Novartis generic unit on plant problems", provided this information from an FDA letter about the problems found by inspectors at a North Carolina Sandoz manufacturing site:

"We question the continued distribution of this product until better process controls are implemented and process validation is completed," the FDA letter said.

"We are also concerned that the problems noted in the metoprolol validations could be indicative of problems and poor decisions made with other product validations," the agency said.

Novartis sought to downplay this August 2008 FDA warning letter to Sandoz, according to the August 26 Reuters article:

Novartis spokesman Eric Althoff said the FDA's concerns were "primarily about documentation and validation."

"We are working together with the FDA to solve the problem," he said.

It is unclear as of August 26 whether Sandoz will cease distribution of its metoprolol succinate ER tablets (generic Toprol XL) and/or issue a recall of this medication.  We will be watching for these possible related developments.

In addition, we will post a link to the Sandoz warning letter regarding its metoprolol succinate ER tablets (generic Toprol XL) when this letter is available on the FDA web site.

P.S.  This August 12, 2008 FDA Warning Letter (08-ATL-13) concerns the Sandoz manufacturing facility located at 4700 Sandoz Drive, Wilson, North Carolina.  (8/26/08)