Alvogen announced a voluntary recall of 7 lots of Clindamycin Injection ADD-Vantage vials after detecting microbial growth during a routine simulation of Hospira’s manufacturing process.
If the contaminated product is administered, the patient may experience adverse events such as fever, chills, and malaise. Serious adverse events may also result, including systemic invasive mycoses or systemic bacterial sepsis.
The affected products were distributed to wholesalers between May 2016 and June 2017. The Lot # and drug strengths are as follows:
- 73-154-EV, 300mg/2mL
- 68-104-EV, 600mg/4mL
- 73-155-EV, 600mg/4mL
- 73-156-EV, 600mg/4mL
- 68-105-EV, 900mg/6mL
- 68-106-EV, 900mg/6mL
- 73-157-EV, 900mg/6mL
Clindamycin Injection, a lincosamide antibiotic, is indicated to treat serious infections caused by susceptible bacteria. It should be reserved for patients with penicillin allergies or for whom a penicillin is inappropriate.
Alvogen has not received any reports of adverse events associated with use of the product. The Company is notifying its customers and distributors to arrange for return of all impacted products. Anyone in possession of the recalled products should discontinue use and quarantine them immediately.
Alvogen issues voluntary nationwide recall of clindamycin injection due to a potential for a lack of sterility assurance [press release]. Washington DC: United States Food and Drug Administration. Published June 16, 2017. Accessed June 6, 2017.
This article originally appeared on MPR