Alvogen Recalls Clindamycin Injection Because of Sterility Problems
The company has voluntarily recalled Clindamycin Injection USP ADD-Vantage Vials to the hospital/retail level because of a lack of sterility assurance.
On June 16, 2017, Alvogen announced it was voluntarily recalling seven lots of Clindamycin Injection USP ADD-Vantage Vials, manufactured for Alvogen by Hospira Inc., to the hospital/retail level. The recall is in response to microbial growth detected during a routine manufacturing simulation. This growth shows the potential for possible contamination of product. Hospira, a Pfizer company, also recalled several other products for the same reason.
The company stated in a press release that no adverse events have been reported but they cannot eliminate the “possibility of a breach in sterility assurance in distributed product.” According to Alvogen, patients taking possibly contaminated Clindamycin Injection, USP, which is used to treat infections, “may experience adverse events, ranging from fever, chills and malaise, to severe adverse events including systemic invasive mycoses or systemic bacterial sepsis.”
The recalled product was distributed nationwide in the United States to wholesalers and hospitals between May 2016 and June 2017. Existing inventory should be quarantined and returned to the company. Adverse events can be reported to FDA at www.fda.gov/medwatch/report.htm.
Source: FDA
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