Antibiotic Injection Recalled

Following a customer report of red rubber particles in vials, AuroMedics Pharma is voluntarily recalling 54,720 vials of ampicillin and sulbactam for injection, USP (NDC 55150-117-20), according to the May 16, 2018, US Food and Drug Administration (FDA) Enforcement Report.

The recall affects 3-gram vials, packaged 10 vials per carton, from lots AS0317041-A and AS0317035-A, which expire in August 2019. The vials were distributed within the United States and in Puerto Rico.

Believing the red rubber particles stemmed from a manufacturing issue, AuroMedics Pharma initiated the recall May 1, 2018. At press time, the FDA had not yet issued a recall classification.

Available with a prescription, ampicillin and sulbactam for injection is a penicillin antibiotic used to treat bacterial infections in patients. 

—Jolynn Tumolo

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