A potential breech in sterility assurance resulted in a recall of clindamycin injection.
Alvogen is recalling 7 lots of clindamycin injection USP ADD-Vantage Vials due to microbial growth discovered during a simulation of the manufacturing process. This discovery means that there may be microorganisms in the product, according to the FDA.
If the affected clindamycin injections are administered, the FDA warns that it is probable that patients may experience significant adverse events.
These adverse events can range from fever, chills, and malaise, to more serious events, such as systemic invasive mycoses or systemic bacterial sepsis, according to the press release.
To date Alvogen has not received reports of adverse events related to the affected lots. While the FDA said the risk of receiving an unsterile product is small, the affected products are being recalled at the hospital and retail level.
Clindamycin injection is indicated to treat bacterial infections that can be potentially serious. Drugs.com reports that clindamycin injection can treat lower respiratory tract infections, skin infections, gynecological infections, abdominal infections, septicemia, and bone/joint infections.
Generally, the treatment is for use among patients who are allergic to penicillin or for whom penicillin is an inappropriate treatment. Introducing additional bacteria to these patients may cause a severe, complicated infection.
Alvogen is currently alerting distributers and customers of the recall and is working to arrange for the return of recalled products. They are advising that any affected products should not be used or distributed and should be quarantined, according to the release.
The FDA encourages patients or physicians to report adverse reactions or quality problems with clindamycin injection to the MedWatch Adverse Event Reporting program, the release concluded.