Hospira Issues a Voluntary Recall Due to Mold Contamination
FDA PRESS RELEASE, FOR IMMEDIATE RELEASE — March 11, 2015 — LAKE FOREST, Ill. — Hospira, Inc. (NYSE: HSP), announced today it is initiating a voluntary recall of one lot of Lactated Ringer’s Irrigation, 3000mL (NDC 0409-7828-08, Lot 40-008-JT; Expiry 1APR2016) to the user level (both human and veterinary) due to a confirmed customer report of several dark, fibrous particulates floating within the solution of the primary container. The particulate was confirmed as a common non-toxic, non-invasive mold, Aspergillus kanagawaensis. To date, Hospira has not received reports of any adverse events associated with this issue for this lot.
A loss of sterility is a primary concern when there is a presence of mold in a sterile, nonpyrogenic solution. If contaminated solution is used on a patient it may cause bacteremia, sepsis, septic shock and endocarditis, and death may result. Signs and symptoms may include redness, pain, swelling at the site, fever, shortness of breath, tachycardia, nausea, and vomiting. Septicemia could lead to shock and multi-system organ failure, requiring critical medical intervention. The mold is considered allergenic and exposure to it may induce an allergic response or immune response to the particulate including anaphylaxis.
- The Shortfalls Of Biological Indicators For HPV Decontamination Validation - 7th September 2017
- Global Exclusive License Signed - 23rd May 2017
- Compounded Sterile Drug Product Recalls Regarding Sterility and Quality Control - 23rd May 2017
- The North Carolina Board of Pharmacy has ordered a recall for all lots of non-sterile and sterile products - 23rd May 2017
- Protak trials with Public Health England in 2015 - 23rd May 2017
- Hospira Issues a Voluntary Recall Due to Mold Contamination - 23rd May 2017
- Applications Of Enzyme Indicators Versus Biological Indicators - 23rd May 2017
- Phillip Godden CEO, On Protak, His Passion And Why Enzyme Indicators Are The Future - 23rd May 2017
- The Real Value Of Using Enzyme Indicators For Decontamination Validation - 23rd May 2017
- FDA alert – Voluntary Recall – Potential Impact on Product Sterility - 23rd May 2017