Lupin Pharmaceuticals, Inc. Issues Voluntarily Nationwide Recall of Metformin Hydrochloride Extended-Release Tablets, 500mg and 1000mg Due to the Detection of N-Nitrosodimethylamine (NDMA) Impurity

Lupin Pharmaceuticals Inc. is voluntarily recalling all batches of Metformin Hydrochloride Extended-Release Tablets USP, 500mg and 1000mg to the consumer level. As part of the ongoing assessment and continuation of the dialog with the FDA, additional analysis revealed that certain tested batches were above the Acceptable Daily Intake Limit for the impurity N-Nitrosodimethylamine (NDMA). Out … Continue reading “Lupin Pharmaceuticals, Inc. Issues Voluntarily Nationwide Recall of Metformin Hydrochloride Extended-Release Tablets, 500mg and 1000mg Due to the Detection of N-Nitrosodimethylamine (NDMA) Impurity”

Granules Pharmaceuticals, Inc. Issues Voluntary Nationwide Recall of Metformin Hydrochloride Extended-Release Tablets USP, 750 mg Due to the Detection of N-Nitrosodimethylamine (NDMA) Impurity

Granules Pharmaceuticals, Inc., Chantilly, VA is voluntarily recalling twelve (12) lots of Metformin Hydrochloride Extended-Release Tablets USP, 750 mg, 100 and 500 count bottles within expiry to the consumer level due to the detection of NNitrosodimethylamine (NDMA) levels above the Acceptable Daily Intake Limit. Granules’ test results showed NDMA levels above the FDA acceptable limit … Continue reading “Granules Pharmaceuticals, Inc. Issues Voluntary Nationwide Recall of Metformin Hydrochloride Extended-Release Tablets USP, 750 mg Due to the Detection of N-Nitrosodimethylamine (NDMA) Impurity”

Teva Pharmaceuticals USA, Inc. Initiates Voluntary Nationwide Recall of Metformin Hydrochloride Extended-Release Tablets USP 500 mg and 750 mg Due to Detection of N-Nitrosodimethylamine (NDMA)

Teva Pharmaceuticals USA, Inc. is voluntarily recalling fourteen (14) lots of Metformin Hydrochloride Extended-Release Tablets, USP 500 mg and 750 mg, 100 and 1000 count bottles, in the United States to the consumer-level due to the detection of N-Nitrosodimethylamine (NDMA) levels in excess of the Acceptable Daily Intake Limit (ADI). NDMA is classified as a … Continue reading “Teva Pharmaceuticals USA, Inc. Initiates Voluntary Nationwide Recall of Metformin Hydrochloride Extended-Release Tablets USP 500 mg and 750 mg Due to Detection of N-Nitrosodimethylamine (NDMA)”

FDA Updates and Press Announcements on NDMA in Metformin

The FDA is alerting patients and health care professionals to several voluntary recalls of extended release (ER) metformin by the companies listed below. The companies are recalling metformin due to the possibility the medicines could contain nitrosodimethylamine (NDMA) above the acceptable intake limit. Granules Pharmaceuticals – 12 lots Lupin Pharmaceuticals – All lots (expansion of previous recall) Avkare … Continue reading “FDA Updates and Press Announcements on NDMA in Metformin”

Metformin Recalled Due to Link to NDMA & Cancer

There are several extended-release lots of the type-2 diabetes medication, Metformin, that contain high levels of N-Nitrosodimethylamine (NDMA), a cancer-causing chemical, according to the Food and Drug Administration (FDA). They are asking several drug manufacturers to recall the medication voluntarily. The agency found these high levels primarily in the extended-release formulation of the medication, which … Continue reading “Metformin Recalled Due to Link to NDMA & Cancer”

Metformin on WebMD

Metformin is used with a proper diet and exercise program and possibly with other medications to control high blood sugar. It is used in patients with type 2 diabetes. Controlling high blood sugar helps prevent kidney damage, blindness, nerve problems, loss of limbs, and sexual function problems. Proper control of diabetes may also lessen your … Continue reading “Metformin on WebMD”

Lupin pulls diabetes drug metformin off shelves as carcinogen worries continue to build

Lupin Pharmaceuticals has pulled all lots of metformin after discovering unacceptably high levels of a probable carcinogen, N-Nitrosodimethylamine (NDMA), in tested samples, the drugmaker said Tuesday. The recall includes the 500- and 1,000-milligram versions of extended-release metformin sold in 60-, 90- and 100-count bottles distributed between early November and late May, Lupin said. Read entire … Continue reading “Lupin pulls diabetes drug metformin off shelves as carcinogen worries continue to build”