Sun Pharma, Lupin Voluntarily Recall Select Lots Due to Particulates

Sun Pharmaceutical Industries and Lupin Pharmaceuticals have issued separate voluntary recalls for select products due to particulate matter in vials.

Sun Pharmaceutical Industries, Inc. (SPII), a wholly owned subsidiary of Sun Pharmaceutical Industries, is voluntarily recalling three lots of vecuronium bromide for injection, 10 mg (lyophilized powder), and one lot of vecuronium bromide for injection, 20 mg (lyophilized powder) to the hospital level. The vecuronium bromide for injection has been found to contain particulate matter identified as glass.

The administration of a glass particulate, if present in an intravenous drug, may result in local irritation or swelling in response to the foreign material. More serious potential outcomes would include blockage and clotting in blood vessels, which may be life-threatening. To date (as of January 8, 2018), SPII has not received any reports of adverse events related to this recall.

Vecuronium bromide for injection is used as an adjunct to general anesthesia, to facilitate endotracheal intubation and to provide skeletal muscle relaxation during surgery or mechanical ventilation and is packaged in a glass vial: 10 vials per carton.

Separately, Lupin Pharmaceuticals, Inc. is voluntarily recalling five lots of ceftriaxone for injection, USP, 250 mg, 10 lots of ceftriaxone for Injection, USP, 500 mg, 24 lots of ceftriaxone for Injection, USP, 1 g, and three lots of ceftriaxone for injection, USP 2 g, to the hospital/physician level. The products have been found to contain visual grey particulate matter in reconstituted vials.

Improper piercing and use of a needle greater than 21 gauge (larger internal diameter) while reconstituting the vial, can push rubber flecks into the solution. There were no grey flecks seen prior to the reconstitution of the vials, and the issue was identified upon standard visual inspection prior to patient administration.

If injected, this product (containing rubber particulate matter from the stopper) could cause vein irritation/phlebitis or pulmonary embolic events that could result in permanent impairment of body function or damage to body structures, such as the lungs and vascular system. In addition, as ceftriaxone can be administered intramuscularly, the use of the product may result in local muscle inflammation and/or abscesses. To date (January 5, 2019), the company has not received any reports of adverse events related to the recalled lots.

Ceftriaxone for injection, USP, is used as a sterile, semi-synthetic, broad-spectrum cephalosporin antibiotic for intravenous or intramuscular administration. It is used to reduce the development of drug-resistant bacteria and maintain the effectiveness of ceftriaxone sodium and other antibacterial drugs.

Source: US Food and Drug Administration (Sun Pharma and Lupin)

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