Microbial Growth Leads to Recall of Alvogen Clindamycin Injection

Microbial growth may indicate the presence of microorganisms in the product

Microbial Growth Leads to Recall of Alvogen Clindamycin Injection
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June 20, 2017

Alvogen has recalled seven lots of Clindamycin Injection USP ADD-Vantage Vials due to microbial growth, which may indicate the presence of microorganisms in the product.

This injection is reserved for patients allergic to penicillin who need treatment for a serious infection caused by susceptible bacteria. The affected products were distributed across the country to hospitals and wholesalers between May 2016 and June 2017.

For a full list of the affected lot numbers, expiration dates, dosage strengths, and NDC numbers, see the official release issued by the U.S. Food and Drug Administration (FDA).

Alvogen is issuing an Urgent Drug Recall Notice to inform its distributors and customers and is arranging for all the affected products to be returned. Those in possession of the injections should stop using and distributing them and quarantine them right away. To date, the company has received no reports or adverse incidents related to their use.

If the affected injections are administered, it is reasonably likely that the patient may suffer adverse events such as fever, chills and malaise, systemic invasive mycoses, or systemic bacterial sepsis.

For more information, consumers can reach Alvogen at (844) 842-8672.