Medication Monitor

Generic Name (Trade Name—Company)
June 21, 2017

Clindamycin injection

(No trade name—Alvogen/Hospira)
Product recalled for lack of sterility assurance

Alvogen is voluntarily recalling seven lots of clindamycin injection ADD-Vantage Vials to the hospital/retail level because microbial growth was detected during a routine simulation of the manufacturing process.

Patients who are administered the affected product may experience adverse events ranging from fever, chills, and malaise to severe adverse events, including systemic invasive mycoses or systemic bacterial sepsis.

The possibility of a breach in sterility assurance in the distributed product, while remote, cannot be eliminated, said Alvogen, which had not received any reports of adverse events associated with use of the product as of June 16, 2017.

Use should be reserved for patients who are allergic to penicillin or other patients for whom a penicillin is inappropriate. See the company announcement for list of product lot numbers affected that were distributed nationwide to wholesalers and hospitals between May 2016 and June 2017.