Pharmaceutical

Recall is just the latest in string of manufacturing mishaps for Hospira

Recalls Hospira logo1 Recall is just the latest in string of manufacturing mishaps for HospiraDrug maker Hospira Inc.’s announced this week that it was recalling some injectable drugs because glass strands were found the vials, and if used could cause a host of complications from minor vein inflammation to serious organ failure. The recall is one of nearly a half-dozen manufacturing mishaps involving the company’s products so far this year.

This week’s recall involved metoclopramide (Reglan), used to treat severe acid reflux, and ondansetron (Zofran), used to prevent nausea and vomiting in cancer patients. The drugs were distributed nationwide to wholesalers, hospitals and pharmacies from June to September. Hospira blamed the issue on its glass supplier.

No reports of injury have been reported to date. If the glass strands become dislodged from the vial and are injected into patients, minor injuries could result. However children, the elderly, and people with compromised immune systems could experience more serious complications.

The recall follows a similar action in August involving an amino acid solution used as a nutritional treatment. A recall was ordered after a patient reported seeing a human hair floating in the solution.

In May, the Food and Drug Administration (FDA) cited the company’s India manufacturing facility for unsanitary practices including failing to clean surfaces and use of damaged gloves when handling sterile products. In March, the agency raised quality-control concerns over defective equipment at Hospira’s North Carolina plant. A month earlier, the company’s corporate headquarters in Illinois was slapped with quality control violations over medical device and customer complaint reporting.

Source: Law 360