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# Alvogen Recalls 7 Clindamycin Lots Over Sterility Issues
- URL: https://www.fdaweb.com/alvogen-recalls-7-clindamycin-lots-over-sterility-issues/
- Published: 2017-06-19T12:00:00.000Z
- Updated: 2026-09-14T22:30:05.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5138967

Alvogen has recalled 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. The drug is indicated for treating serious infections caused by susceptible bacteria. Its use should be reserved for penicillin-allergic patients or other patients for whom penicillin is inappropriate. The product is manufactured for Alvogen by Pfizer’s Hospira drug unit.

  
“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,” an FDA [recall notice](https://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm563546.htm?ref=fdaweb.com) says. “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.”