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Posted August 28, 2008

FDA Finds Fault with Generic Toprol XL -- Problems Reported Earlier by

On August 12, 2008, the U.S. FDA sent a letter to Sandoz Inc. warning of violations in its manufacture of Metoprolol Succinate ER tablets and other drug products. Sandoz's Metoprolol Succinate ER tablets are generic versions of Toprol XL.

In March 2008, reported on consumer complaints with Sandoz's Metoprolol Succinate ER. As described in the report, consumers have experienced increased blood pressure, increased heart rate and ectopic beats, as well as side effects such as nausea, dizziness and headaches when switched from Toprol XL to Metoprolol Succinate ER. noted that the Sandoz formulation of the product is different from Toprol XL and dissolves in a different manner.

In its letter to Sandoz, the FDA states that, based on an inspection of a North Carolina plant in March 2008, Sandoz failed to appropriately validate the manufacturing process for Metoprolol Succinate (25 and 50 mg). Some lots were found to fail tests for content uniformity or dissolution. The FDA noted that Sandoz's practices represented a "moving target of quality."

The FDA notes that Sandoz did not conduct timely investigations of lots that failed dissolution testing. In addition, Sandoz chose to continue to release product even after being notified of violations.

The FDA concluded that Sandoz does "not provide a high level of assurance" that its process is "capable of producing a product that meets specifications." The FDA added, "We question the continued distribution of this product until better process controls are implemented and process validation is completed." The FDA requires that Sandoz take prompt action to correct the violations.