Nostrum recalled four lots of its metformin tablets after finding levels of N-Nitrosodimethylamine, or NDMA, above the FDA’s acceptable daily intake level. Metformin is intended to improve blood glucose control in adults with Type 2 diabetes.
Nostrum joins the list of over a dozen drugmakers who have recalled their metformin products since the FDA first announced in May that it had found unacceptable levels of NDMA in metformin. The impurity was originally found by online pharmacy Valisure in early March.
Nostrum said its metformin pills were distributed nationwide to wholesalers, and it hasn’t received any adverse event reports related to the drug.
The drugmaker also warned that it could be dangerous for patients with Type 2 diabetes to stop taking their metformin before talking to a healthcare provider.
More articles on pharmacy:
Mylan, Pfizer get federal OK for merger with Upjohn
Novartis adds new restriction to 340B discount policy
Virginia pharmacist gets 2 years in prison for prescription drug scheme
Becker’s 3rd Annual Fall Chief Pharmacy Officer Summit is the top tier event that the people leading the future of pharmacy convene. This 3-day event is built specifically for Chief Pharmacy Officers and senior pharmacy leaders. The sessions examine the workforce, financial and clinical priorities shaping pharmacy today. Becker’s is where candid discussions flourish and new ideas thrive. Becker's 3rd Annual Fall Chief Pharmacy Officer Summit