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FDA Safety Alerts

January 9, 2019

These Food and Drug Administration (FDA) safety alerts were posted this week:

 

Medtronic Recalls Synergy Cranial Software and StealthStation S7 Cranial Software

Medtronic is recalling the Synergy Cranial Software and StealthStation S7 Cranial Software used with the StealthStation Surgical Navigation System due to reports of incorrect information displaying during biopsy procedures that could result in serious or life-threatening patient harm. More Information.

 

Recall of Vecuronium Bromide by Sun Pharmaceutical Industries

Sun Pharmaceutical Industries is voluntarily recalling 3 lots of vecuronium bromide for injection, 10 mg (lyophilized powder), and 1 lot of vecuronium bromide for injection, 20 mg (lyophilized powder), because the product has been found to contain particulate matter identified as glass. More Information.

 

Recall of Ceftriaxone by Lupin Pharmaceuticals

Lupin Pharmaceuticals Inc. is voluntarily recalling 5 lots of ceftriaxone for injection, 250 mg, 10 lots of ceftriaxone for injection, 500 mg, 24 lots of ceftriaxone for injection, 1 g, and 3 lots of ceftriaxone for injection, 2 g, because the products have been found to contain visual grey particulate matter in reconstituted vials. More Information.