Sagent Latest Drugmaker to Recall Leaky Injectables

Sagent Pharmaceuticals is the latest drugmaker to recall products with leaky containers, notifying healthcare providers that two lots of its Zoledronic Acid Injection product may not be sterile after finding that four premix bags had been compromised.

The leaks were “readily apparent” during an investigation conducted by the drugmaker in response to a complaint, Sagent said, adding that it is not aware of any adverse events connected to the recalled lots.

Sagent is investigating the issue and working with its Swiss contract manufacturer ACS Dobfar Info SA for a solution, Sheila Moran, vice president of quality assurance for Sagent, said March 6. The contractor believes some checks weren’t performed during in-process manufacturing and is looking to buy new technology that could improve leak detection, she added.

Sagent doesn’t believe the recall will impact supplies of Zoledronic Acid Injection, a bisphosphonate used to treat Paget’s disease, a chronic condition that affects bones.

Sagent isn’t the only drugmaker to struggle recently with leaky bags. Baxter also this week recalled a single lot of dialysis solution after mold formed due to leaks in the solution’s container.

Sagent has faced other quality issues before. The drugmaker last June recalled 54 lots of Vecuronium Bromide for Injection 10 mg due to elevated impurity levels. Sagent has said it wasn’t aware of any adverse events related to the affected drugs.

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