Recall of Clindamycin Injection ADD-Vantage Vials by Alvogen
Alvogen is voluntarily recalling seven lots of Clindamycin Injection USP ADD-Vantage Vials to the hospital/retail level due to microbial growth detected during a routine simulation of the manufacturing process, which represents the potential introduction of microorganisms into the product. Clindamycin Injection is manufactured for Alvogen by Hospira 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.
See the MedWatch Safety Alert which includes a link to the Company Announcement for the list of product lot numbers affected which were distributed nationwide in the USA to wholesalers and hospitals between May 2016 and June 2017.
Alvogen is notifying its distributors and customers via an Urgent Drug Recall Notice and is arranging for return of all recalled products. Anyone with existing inventory is requested to stop use and further distribution of the impacted lots, and quarantine the product immediately.
Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program.
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