Pfizer’s Hospira Initiates Recall of 3 Drug Lots Due to Particulate Concerns

Pfizer's Hospira Initiates Recall of 3 Drug Lots Due to Particulate Concerns

Hospira, a subsidiary of Pfizer, has taken the proactive step of issuing a voluntary recall for specific injectable medications, namely sodium bicarbonate and lidocaine HCI, due to potential glass particle contamination in the vials.

On Monday, Hospira announced the recall of a single lot of 4.2% sodium bicarbonate injection set to expire in August 2024. Additionally, the company recalled lots of two lidocaine HCI injections: one with a June 2024 expiration date and the other with a July 2024 expiration date. The official recall notice from Hospira can be found on the FDA’s website.

These products were distributed across the United States, including the territory of Puerto Rico, in October of the previous year. Importantly, Hospira has stated that there have been no reported adverse events associated with the use of these products.

Also Read: Novartis Recalls Lot Of Sandimmune Due To Crystal Formation In Oral Solution

Sodium bicarbonate injection is a medication commonly employed in the treatment of metabolic acidosis, often arising from severe renal disease, uncontrolled diabetes, cardiac arrest, or other severe medical conditions.

Lidocaine HCI injection, on the other hand, serves as an anesthetic for patients undergoing specific medical procedures and is used in the acute management of ventricular arrhythmias.

Hospira has faced challenges related to manufacturing issues and recalls in the past. In late 2022, the company recalled a lot of vancomycin hydrochloride injection vials due to the presence of glass particles. In July of that same year, another recall was initiated for a lot of the anaesthetic propofol following the discovery of “visible particulate” in a vial during a routine inspection.

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Going back to 2017 and 2018, Hospira experienced a series of recalls related to injectable medications, primarily stemming from issues with particulate matter, microbial growth, and even the discovery of a human hair in a syringe within one lot of 25% dextrose injection for infants.

It’s important to note that Pfizer acquired Hospira for $17 billion in 2015, and the company continues to work diligently to address and resolve such issues to ensure the safety and reliability of its pharmaceutical products.

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