American Regent Issues Voluntary Recall of Hypertension Medication

American Regent notified customers and distributors of its voluntary recall of a single lot of methyldopate HCL injection due to the presence of translucent particles of glass flakes. The glass flakes are said to range in size from less than 50 microns to 200 microns. This recall is the latest in a growing list of products pulled by American Regent over visible particulate matter.

Adverse events may occur as a result of using the recalled solution, examples of which include the disruption of blood flow in the small blood vessels of the lung, localized inflammation and granuloma formation. American Regent has issued a statement stressing that the voluntary recall is for only lot number 0152 and no other. The company is also urging customers in possession of the affected lot to immediately stop using the product. At present, no adverse reactions associated with the recalled lot have been reported.

Methyldopate HCL Injection, USP is used in the treatment of hypertension when parenteral medication is indicated.

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