Question 1

Is Metformin Hydrochloride Extended-release Tablets USP, 500 mg, 60 count bottle, Rx only, Manufactured for Lupin Pharmaceuticals, Inc., Baltimore, MD Manufactured by: Lupin Limited Goa INDIA (NDC 68180-336-07) recalled?

Accepted Answer

Lupin Pharmaceuticals Inc. has voluntarily recalled 6,540 bottles of Metformin Hydrochloride Extended-release Tablets USP (500 mg, 60-count bottles) after FDA testing revealed the presence of an impurity called N-Nitrosodimethylamine (NDMA). NDMA is classified as a probable human carcinogen, meaning long-term exposure to levels above acceptable limits may increase the risk of cancer. This recall affects generic Metformin (an Rx medication) with NDC number 68180-336-07 and expiration date 12/2020. Consumers should continue taking their medication but contact their doctor or pharmacist immediately for a replacement or alternative treatment to avoid health risks from stopping their diabetes medication abruptly.

Question 2

What should I do?

Accepted Answer

Check your prescription bottle for 'Metformin Hydrochloride Extended-release Tablets USP, 500 mg' with NDC 68180-336-07 and Batch/Lot number G901203 with an expiration date of 12/2020. If you identify your bottle as part of this recall, do NOT stop taking your medication until you have spoken with your healthcare provider or pharmacist, as stopping diabetes medication suddenly can pose serious health risks. Contact your healthcare provider or pharmacist to obtain a replacement prescription or an alternative treatment for your condition. Return any remaining tablets from the affected lot to your pharmacy for a refund and further instructions. Contact Lupin Pharmaceuticals Inc. for more information or to report any issues at the manufacturer's contact details found on their website or through the pharmacy where the product was purchased. For additional questions or to report a complaint, call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls.

Question 3

How do I get a refund or replacement?

Accepted Answer

Contact your healthcare provider or pharmacist for guidance. Return any unused product to the pharmacy for a refund.

Lupin Pharmaceuticals Inc.: Metformin Hydrochloride Extended-release Tablets USP Recalled for Impurity

Summary

Risk

What You Should Do

Your Remedy Options

Affected Products

Additional Information

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