Provider Alert! Metformin ER drug recall due to NDMA impurity (Amneal Pharmaceuticals)
Attention: All Providers and Pharmacies
Effective Date: June 4, 2020
Call to action: Amneal Pharmaceuticals LLC has issued a voluntary recall of several lots of Metformin Hydrochloride Extended Release Tablets USP 500mg, and 750mg. Amneal’s Metformin Hydrochloride Immediate Release Tablets are not affected by this recall.
The recall is due to discovery of an impurity (N-nitrosodimethylamine [NDMA]) in the finished product. NDMA is classified as a probable human carcinogen that may be found in certain foods, drinking water, and industrial processes. Amneal has not received reports of adverse events related to this recall to date.
Metformin is a preferred first-line treatment for Type 2 diabetes based on safety, efficacy, and low cost. Potentially impacted customers are being notified with a recommendation to not stop taking their medication until discussing with their doctor.
How this impacts providers: Members may reach out to providers upon receipt of a recall letter from their health plan and/or pharmacy. Pharmacies may dispense another manufacturer’s metformin due to this recall.
Next steps for providers: Providers should stay vigilant about additional recalls related to metformin. The Federal Drug Agency (FDA) is investigating if other manufacturers may be impacted by this same impurity.
If you have any questions, please email Provider Network Management at: providerrelations@texaschildrens.org.
For access to all provider alerts, log into:
www.thecheckup.org or www.texaschildrenshealthplan.org/for-providers.
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