“Should a patient receive an injectable product containing glass particulate matter as a result of this issue, the patient may experience serious adverse events. Potential complications related to injection of visible and subvisible inert particles include inflammation of a vein, granuloma, and blockage of blood vessels or life-threatening blood clot events.”
On December 21, 2023, Hospira, Inc. initiated a voluntary nationwide recall for multiple batches of injectable products, Sodium Bicarbonate Injection and Atropine Sulfate Injection, after identifying the potential presence of glass particulate matter. The recall was triggered following product inspection, which detected the presence of glass particulates in some batches. However, the root cause of how these affected products passed through quality checks and were released to the market remains undisclosed.
Glass particles in injectable drugs pose a serious risk to patient safety, as they can lead to adverse events such as embolism, stroke, or infection if administered.
Hospira emphasized that healthcare professionals are directed to inspect the product visually before use. However, variables such as lighting, background contrast, and inspection methodology at the point of care are less controlled compared to standardized visual inspection methods used in pharmaceutical manufacturing. This raises concerns about the potential efficacy of visual inspections performed by healthcare providers at the point of care, especially when compared to the stringent quality checks conducted at manufacturing facilities.
The recall highlights the critical role of thorough visual inspection and data review during the drug manufacturing process. Ensuring that all batches meet the required acceptance criteria for particulate matter before being released to the market is essential in safeguarding patient safety.
Lessons Learned:
Hospira’s proactive approach in identifying and recalling these products underscores the company’s commitment to quality. Though no adverse events had been reported at the time of the recall, the incident serves as a reminder to the pharmaceutical industry of the importance of maintaining a robust visual inspection and particulate control program to avoid similar issues in the future.
In conclusion, this recall demonstrates the importance of stringent quality controls in the manufacturing process, especially when using materials like glass, which, while common in pharmaceutical packaging, can introduce risks if not properly managed.
For the most up-to-date and accurate information on drug product recalls, please visit the FDA’s official website at: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts
