The FDA recently issued two announcements on its official website. Pfizer, Inc. voluntarily recalled 4.2% sodium bicarbonate injection, 8.4% sodium bicarbonate injection, atropine sulfate injection, bleomycin for injection and other products. The reason for the recall was that there might be glass particles in the above products.
FDA notifications show that if patients are treated with drugs containing glass particles, serious adverse events may occur. Potential complications include phlebitis, vascular blockage, and even life-threatening thrombosis. The likelihood and severity of these events depend on various factors, including the size and quantity of the glass particles as well as individual patient factors such as age and baseline organ function.
No related serious adverse events have been reported.
Among the recalled products, the presence of glass particles in Bleomycin for injection was initially discovered and reported by customers, while issues with other products were identified during product inspections. The website of the National Medical Products Administration shows that none of the aforementioned Pfizer drugs have entered the Chinese market.
Public data shows that sodium bicarbonate injection is mainly used to treat acidosis and is a common emergency medicine in clinical settings; Bleomycin for injection is suitable for various malignant tumors such as skin malignancies, head and neck tumors (maxillary sinus cancer, pharyngeal cancer, laryngeal cancer, oral cancers like tongue cancer, lip cancer, etc.), lung cancer (especially primary and metastatic squamous cell carcinoma), esophageal cancer, and malignant lymphoma. Fortunately, Hospira (the sterile injectable division under Pfizer) has not received any serious adverse events related to the aforementioned issues.
Two recall notices both point to Pfizer's sterile injection department — Hospira, which was acquired by Pfizer. In February 2015, Pfizer signed an agreement with Hospira to acquire it for $90 per share, totaling $17 billion. At that time, Pfizer was attracted by Hospira's product pipeline, whose main products were sterile injectables and biosimilars. Its specialized injectables business, including generic injectables, ranked first in scale in the United States. When acquiring Hospira, Pfizer predicted that the market for sterile generic injectables would grow at an annual rate of 10% until 2020, driving the overall injectables market to grow by 6% annually, representing a market space of $70 billion.
Multiple pharmaceutical companies have experienced quality and safety issues.
This is not the first time Hospira has had drug quality issues.
In December 2022, Hospira recalled a batch of Vancomycin Hydrochloride Injection for reasons similar to this recall—glass particles were found in the drug. Vancomycin Hydrochloride is mainly used to treat severe or serious infections caused by methicillin-resistant staphylococcus sensitive strains and is effective against staphylococcal endocarditis, sepsis, bone infections, lower respiratory tract infections, skin and skin structure infections. The FDA stated in its notification that if administered intravenously with glass particles present, patients may experience various adverse reactions, including local irritation or swelling, vasculitis/phlebitis, microvascular obstruction, and pulmonary embolism.
In August 2022, Hospira also recalled a batch of propofol injectable emulsion (containing benzyl alcohol) for the same reason: the possible presence of visible particles in the product.
In addition to Pfizer, several other companies have also encountered similar issues.
Due to the presence of glass particles, Gilead voluntarily recalled two batches of injectable Remdesivir in December 2021. This recall was triggered by customer complaints about glass particles found in the Remdesivir injection solution, which Gilead confirmed after investigation, leading to the recall of two batches of 100-milligram Remdesivir injections. In October 2021, Merck voluntarily recalled a batch of 500-milligram injectable Daptomycin across the United States for the same reason—complaints were received, and subsequent testing confirmed the presence of glass particles in that batch.
Reporter Zhang Xiulan of The Beijing News
Proofread by Lu Qian