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Thursday, March 7, 2019

RECALLS

McDaniel Life-Line LLC Issues Voluntary Worldwide Recall of Life-Line Water

McDaniel Life-Line LLC is voluntarily recalling all lots of Life-Line Water to the consumer level. This product is being recalled because FDA analysis found the product to be contaminated with Pseudomonas aeruginosa.

Use of the contaminated product has a remote probability of necessitating medical or surgical intervention to preclude or reverse permanent damage to a body structure or function. To date, McDaniel Life-Line LLC has not received any reports of adverse events related to this recall.

The product can be taken internally or applied externally to the skin. The product is packaged in 1-gallon bottles. The affected Life-Line Water recall includes all lots.

The product was distributed in the United States and Canada to individuals via internet sales@lifelinewater.com.   Read more....


American Health Packaging Issues Voluntary Nationwide Recall of Valsartan Tablets Due to the Detection of NDEA (N-Nitrosodiethylamine) Impurity
American Health Packaging is voluntarily recalling one lot of Valsartan Tablets, USP, 160 mg to the consumer level due to the detection of trace amounts of an unexpected impurity found in the finished drug product. The impurity detected in the finished drug product is N-Nitrosodiethylamine (NDEA), which is a substance that occurs naturally in certain foods, drinking water, air pollution, and industrial processes, and has been classified as a probable human carcinogen as per International Agency for Research on Cancer (IARC) classification. This recall is being initiated in response to the recall by the manufacturer (Aurobindo Pharma USA, Inc.), which included the affected lot that was repackaged by American Health Packaging.

Valsartan Tablets USP are indicated to control high blood pressure and for the treatment of heart failure.

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