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Sandoz Inc., recently received a Warning Letter, 08-ATL-13, from the FDA, advising Sandoz that an inspection of Sandoz’s manufacturing facility located at 4700 Sandoz Drive, Wilson, North Carolina revealed that Sandoz was manufacturing Metoprolol tablets (used to treat hypertension) in violation of quality control procedures and guidelines.

 

These violations included multiple failures to ensure that the tablets were the proper dosage strength and were of quality ingredients.  It was also discovered that Sandoz had failed to comply with their own internal company regulations and failed to undertake quality control steps or investigate problems that were brought to light within the company.  Additionally, the FDA noted that Sandoz failed to inspect Doxycycline Hyclate DR Capsules, Lisinopril Tablets, Alprazolam ER Tablets, Fentanyl Citrate Lozenges, Azithromycin for Oral Suspension and Anagrelide HCl Capsules.

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