Hospira Recalls Hydromorphone HCl Injection

News
Article

The company is recalling three lots of Hydromorphone HCl Injection USP CII 10 mg/mL, 1 mL in 2 mL Single Dose Vials because of possibly empty or cracked vials.

Hospira, a Pfizer company, announced on March 5, 2018, that it was voluntarily recalling three lots of Hydromorphone HCl Injection USP CII 10 mg/mL, 1 mL in 2 mL Single Dose Vials to the hospital level. The recall was initiated on Feb. 7, 2018 because some units might have empty or cracked vials. Hydromorphone HCl, an opioid agonist, is used to manage severe pain.

According to the company, cracked vials might lead to a compromise in sterility, which may cause bloodstream infections. In addition to sterility concerns, the cracked vials could result in injury to healthcare professions. As of March 5, Hospira has not received any reports of adverse events associated with the recalled product.

The affected lots have expiration dates of November 1, 2018, September 1, 2018, and October 1, 2018 and were distributed nationwide. The company is advising distributers and hospitals to stop use and distribution of the recalled lots. Adverse events may be reported to FDA’s MedWatch program.

Source: FDA

 

Recent Videos
Tore Bergsteiner from MAIN5 discusses the most pertinent and impactful bio/pharma industry trends from 2024.
Simon Wright from Almac Pharma Services chats about shifting demand for commercial manufacturing services and how service providers are adapting to meet demand.
Ian Lafferty from Upperton discusses the trends and challenges facing sterile manufacturing and how partnering with CDMOs can help innovators progress to the market.
Miguel Forte from ISCT and Kiji Therapeutics talks about the potential impact of a changing European political landscape.
Miguel Forte from ISCT and Kiji Therapeutics provides his insights into the changing political landscape in the US as well as legislative and regulatory adjustments
Miguel Forte from ISCT and Kiji Therapeutics chats about expectations for 2025 and the future technology agenda for industry.
Sheryl Johnson from Orbia Fluor & Energy Materials chats about gender diversity, how women are helping to advance innovation, sustainability challenges, and progress in the field of inhaled drugs.
Mike Baird from Schlafender Hase gives his predictions for how AI and ML may find use in the industry moving forwards and provides some predictions about M&A and the changing US government administration.