Hospira Issues Voluntary Recall Due to Iron Oxide Particulate in Vials
Hospira recalls one lot of Lidocaine HCI Injection, USP, 2%, 20 mg per mL single-dose vial, preservative-free, due to particulate matter.
Hospira, Inc., announced a voluntary recall of one lot of single-dose vials of Lidocaine HCI Injection, due to a customer complaint of discolored product with visible particles, identified as iron oxide, in the solution. Particulate also was embedded in the molded glass container, according to the recall announcement from Hospira.
The company has attributed the embedded particulate to supplier’s glass defect and is working with its supplier on implementing corrective and preventive actions.
The recall, which is to the user level, is for Lidocaine HCI Injection, USP, 2%, 20 mg per mL, 5 mL single-Dose Vial, Preservative-Free (NDC 0409-2066-05; Lot 25-550-DD, Expiry 1JAN2015). The product was packaged 10 units per carton/180 units per case in single-dose glass fliptop vials and was distributed nationwide to distributors/wholesalers, hospitals, and clinics from June 2013 through July 2013.
Risk factors associated with the particulate include the potential for particulate to be injected and/or a delay in therapy. Hospira reports that it has not received reports of any adverse events associated with this issue for this lot.
Source: FDA and Hospira
Drug Solutions Podcast: A Closer Look at mRNA in Oncology and Vaccines
April 30th 2024In this episode fo the Drug Solutions Podcast, etherna’s vice-president of Technology and Innovation, Stefaan De Koker, discusses the merits and challenges of using mRNA as the foundation for therapeutics in oncology as well as for vaccines.
Understanding the Variability in Bioburden Test Results in Biomanufacturing
May 7th 2025This article explores the impact of test volume, microbial distribution, and dilution errors on bioburden testing variability. It presents statistical approaches to estimate percentage error and discusses strategies to optimize microbial enumeration techniques in biopharmaceutical quality control.
Drug Solutions Podcast: Gliding Through the Ins and Outs of the Pharma Supply Chain
November 14th 2023In this episode of the Drug Solutions podcast, Jill Murphy, former editor, speaks with Bourji Mourad, partnership director at ThermoSafe, about the supply chain in the pharmaceutical industry, specifically related to packaging, pharma air freight, and the pressure on suppliers with post-COVID-19 changes on delivery.
Intertek to Expand UK GMP Facility with 6000 Square Feet of Lab and Office Space
May 7th 2025The company said the expansion is in response to globally rising demand for inhaled biologics, which offer distinct advantages in route of administration, but can be challenging products for developers.
