What is Clindamycin Injection?
Clindamycin Injection is used to treat a wide variety of bacterial infections. It works by stopping the growth of bacteria. Its use should be reserved for penicillin-allergic patients or other patients for whom, in the judgement of the physician, a penicillin is inappropriate. It should not be used to treat meningitis.
The medication is given by injection into a vein or muscle as directed by your healthcare physician, usually 2 to 4 times a day and the dosage is based on your medical condition and response to the treatment. In children, the dosage is also based on weight.
Alvogen is voluntarily recalling seven lots of Clindamycin Injection USP ADD-Vantage Vials due to microbial growth detected during a routine simulation of the manufacturing process, which represents the potential introduction of microorganisms into the product. Clindamycin Inection is manufactured for Alvogen by Hospita Inc., a Pfizer Company.
In the event that impacted product is administered, there is a reasonable probability that the patient 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 distributed product, while remote, cannot be eliminated. To date, Alvogen has not received any reports of adverse events associated with use of the product, but it is always better to be safe than sorry.
The full list of product lot numbers affected which were distributed nationwide in the USA to wholesalers and hospitals between May 2016 and June 2017 can be found on FDA’s MedWatch Safety alert page.
What do you have to do next?
If you are in possession of the affected lots, you are requested to immediately cease use of it and for retails and hospital customers to cease distribution of the impacted lots and quarantine the product immediately.
The FDA is encouraging all health care professionals and patients to report any adverse events or side effects related to the use of these to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program online or call 1-800-332-1088 (US Toll-free number).
Read the full FDA alert here.