American Regent is conducting a nationwide voluntary recall of a single lot (#0152) of its Methyldopate HCL Injection, USP, according to an FDA release.
The product is Methyldopate HCL Injection, USP, 250 mg/5 mL (50mg/mL), 5 mL Single Dose Vial; NDC # 0517-8905-10, Lot #0152, with an expiration date of March 2012.
No other lots of Methyldopate HCL Injection, USP are subject to this recall.
The recall was initiated because some of the vials of the lot contained translucent visible particles consistent with glass delamination. The glass particles ranged in size from <50 microns to 200 microns.
Potential adverse events after intravenous administration of solutions containing particulates may include disruption of blood flow within small blood vessels in the lung, localized inflammation and granuloma formation.
American Regent has not received any reports of adverse events related to this recall.
Methyldopate HCL Injection, USP is used to treat hypertension, when parenteral medication is indicated.
Read the FDA news release about the voluntary recall by American Regent.
Related Articles on FDA Recalls:
Boston Scientific Recalls iCross Coronary Catheters for Ultrasound Imaging
Beckman Coulter Recalls Ion Selective Electrolyte Flow Cell
Aidapak Services Recalls All Repackaged Pharmaceuticals Due to Potential Cross Contamination With Beta-Lactam Products