FDA: Despite Improvement, Particulate-Related Injectables Recalls Remain A Concern

The US FDA reports that particulate contamination was the second leading cause of recalls for injectable drugs over a 10-year period. Yet the good news is that the recalls attributed to visible particle contamination has actually gone down. FDA official says it may be premature to celebrate, more work is needed to bring these recalls down and improve the quality of injectable products.

Sterile bottles and ampoules on the dispensing line.Sealed ampoules with medicine.Sterile capsules for injection. Bottles on the bottling line of the pharmaceutical plant.
Sterile vials

Over the past 10 years there has been improvement in the number of recall events attributed to particle contamination of injectable drugs, yet manufacturers need to work harder to improve the quality of these products as the number of injectable recalls overall is still “significant,” a US FDA official says.

To address this problem, the agency is developing a guidance on visual testing programs to improve the quality of sterile injectable drugs, yet in the meantime an official advises industry...

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