The QMN Weekly Bulletin

The FDA is questioning a decision by Novartis subsidiary Sandoz to continue distributing generic versions of Toprol XL after it found the company did not adequately validate its production process.

“We question the continued distribution of this product until better process controls are implemented and process validation is completed,” the FDA tells Sandoz in a warning letter posted on its website.

“You originally decided to temporarily suspend distribution of metoprolol 25- and 50-mg tablets [generic Toprol XL] until the available pre-compression and dissolution data was reviewed,” the FDA says in the Aug. 12 letter. “However, you have decided to resume distribution of these products based on your rationale that successful, routine, finished-product testing of manufactured lots is sufficient proof that the product is of acceptable quality.”

The company manufactures metoprolol succinate at its facility in Wilson, N.C. The warning letter resulted from a March inspection.

Sandoz is collaborating with the FDA to resolve the agency’s concerns and says all products released and distributed met all specifications, according to a company statement about the warning letter. The letter is available at www.fda.gov/foi/warning_letters/s6891c.pdf.